HIV treatment interruptions
|Also listed as: Structured treatment interruptions, Strategic treatment interruptions||Integrative Therapy Quick Links:|
- Acquired immune deficiency syndrome, acquired immunodeficiency syndrome, AIDS, antiretroviral therapy, antiretrovirals, ART, biopsy, CD4 cell count, CD4 cells, drug holiday, drug resistance, HAART, highly active antiretroviral therapy, HIV, human immunodeficiency virus, immune, immune defense system, immune system, immunocompromised, immunodeficiency, infection, OI, opportunistic infection, SIT, STI, superinfection, treatment adherence, viral infection, viral load, virus, weakened immune system, white blood cells.
- Structured treatment interruptions (STIs), also called structured intermittent therapy (SIT) or drug holiday, describes scheduled breaks in drug regimens for HIV.
- Researchers began studying treatment interruptions after it was reported that a handful of HIV patients were able to maintain a very low number of viral particles in the blood (viral load) when they took a break from treatment. It was suggested that STIs might offer benefits for HIV patients, including reduced cost and side effects.
- However, large-scale studies have not found any benefit in stopping treatment. In fact, research suggests that stopping and starting treatment can have serious negative effects on an HIV patient. STIs may increase the rate of disease progression to AIDS (acquired immune deficiency syndrome) and may lead to an increased risk of infection and drug resistance. Once a patient becomes resistant to a drug, that particular medication is no longer effective, even if it is taken in the future.
- It is possible that future studies may find benefit for treatment interruptions in specific subgroups of HIV patients, such as children.
- Patients should not discontinue or alter their medications without first consulting their healthcare providers.
- This information has been edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com).
- AIDSmap.com. .
- Holkmann Olsen C, Mocroft A, Kirk O, et al. Interruption of combination antiretroviral therapy and risk of clinical disease progression to AIDS or death. HIV Med. 2007 Mar;8(2):96-104.
- Natural Standard: The Authority on Integrative Medicine. .
- Strategies for Management of Antiretroviral Therapy (SMART) Study Group; El-Sadr WM, Lundgren JD, Neaton JD, et al. CD4+ count-guided interruption of antiretroviral treatment. N Engl J Med. 2006 Nov 30;355(22):2283-96.
- The Body: The Complete HIV/AIDS Resource. .
- Walmsley SL, Thorne A, Loutfy MR, et al. A Prospective Randomized Controlled Trial of Structured Treatment Interruption in HIV-Infected Patients Failing Highly Active Antiretroviral Therapy (Canadian HIV Trials Network Study 164). J Acquir Immune Defic Syndr. 2007 Apr 26; [Epub ahead of print].
- Wang YM, Dyer WB, Workman C, et al. Drug resistance and viral evolution in plasma and peripheral blood cells during structured treatment interruption (STI) and non-interrupted HAART. Curr HIV Res. 2007 Mar;5(2):235-50.
- Note: Currently, there is insufficient available evidence on the safety and effectiveness of integrative therapies during HIV treatment interruptions. The integrative therapies listed below should be used only under the supervision of a qualified healthcare provider.
- Unclear or conflicting scientific evidence:
- Aloe vera:
Clear gel from the pulp of Aloe vera leaves has been used on the skin for thousands of years to treat wounds, skin infections, minor burns, and other skin conditions. Although aloe has been suggested as a possible treatment for HIV infection, further research is needed before a firm conclusion can be made.
- Avoid if allergic to aloe or other plants of the Liliaceae family (garlic, onions, and tulips). Avoid injecting aloe. Do not apply to open skin, surgical wounds, or pressure ulcers. Avoid taking by mouth with diarrhea, bowel blockage, intestinal diseases, bloody stools, or hepatitis. Avoid with a history of irregular heartbeat (arrhythmia), electrolyte imbalances, diabetes, heart disease, or kidney disease. Avoid taking by mouth if pregnant or breastfeeding.
- Alizarin: Limited available evidence suggests that alizarin may be of benefit in the treatment of viral infections. Additional research is needed in this area.
- Avoid if allergic or hypersensitive to alizarin or any plants in the Rubiaceae family. Alizarin may be toxic and should not be handled for long periods of time, rubbed in the eyes, or eaten. Avoid if pregnant or breastfeeding.
Antineoplastons are substances found in human blood and urine. Preliminary study reported increased energy and weight in patients with HIV who were treated with antineoplaston AS2-1, as well as a decreased number of opportunistic infections and increased CD4 cell counts. However, this evidence cannot be considered conclusive. Currently, there are drug therapy regimens available for HIV with clearly demonstrated effects (highly active anti-retroviral therapy), and patients with HIV are recommended to consult with their physicians about treatment options.
- Avoid if allergic or hypersensitive to antineoplastons. Use cautiously with high medical or psychiatric risk. Use cautiously with an active infection due to a possible decrease in white blood cells. Use cautiously with high blood pressure, heart conditions, chronic obstructive pulmonary disease, liver disease/damage, or kidney disease/damage. Avoid if pregnant or breastfeeding.
- Astragalus: Antiviral effects have been reported in early studies for HIV. Additional research is warranted.
- Avoid if allergic to astragalus, peas, or any related plants or with a history of Quillaja bark-induced asthma. Avoid with aspirin or aspirin products or herbs or supplements with similar effects. Avoid with inflammation (swelling) or fever, stroke, transplant or autoimmune diseases (like HIV/AIDS). Stop use two weeks before surgery/dental/diagnostic procedures with a risk of bleeding and avoid use immediately after these procedures. Use cautiously with bleeding disorders, diabetes, high blood pressure, lipid disorders or kidney disorders. Use cautiously with blood-thinners, blood sugar drugs, or diuretics or herbs and supplements with similar effects. Avoid if pregnant or breastfeeding.
- Beta sitosterol: Beta-sitosterol is found in plant-based foods, such as fruits, vegetables, soybeans, breads, peanuts, and peanut products. It is also found in bourbon and oils (such as olive oil, flaxseed, and tuna). Due to data that suggest immune modulating effects of beta-sitosterol and beta-sitosterol glucoside, these sterols have been studied in combination in the treatment of HIV. Larger populations of patients with HIV should be evaluated in randomized controlled trials to draw any conclusions.
- Avoid if allergic or hypersensitive to beta-sitosterol, beta-sitosterol glucoside, or pine. Use cautiously with asthma or breathing disorders, diabetes, primary biliary cirrhosis (destruction of the small bile duct in the liver), ileostomy, neurodegenerative disorders (like Parkinson's disease or Alzheimer's disease), diverticular disease (bulging of the colon), short bowel syndrome, celiac disease, and sitosterolemia. Use cautiously with a history of gallstones. Avoid if pregnant or breastfeeding.
- Bitter melon: Laboratory studies have shown that a protein in bitter melon called MAP30 may have antiviral activity against HIV. However, this has not been studied in humans. Further research is needed before a firm conclusion can be made.
- Avoid if allergic to bitter melon or members of the Curcurbitaceae (gourd or melon) family. Avoid ingesting bitter melon seeds. Avoid with glucose-6-phosphate dehydrogenase deficiency. Use cautiously with diabetes, glucose intolerance, or with hypoglycemic agents due to the risk of hypoglycemia (low blood sugar). Avoid if pregnant or breastfeeding.
- Blessed thistle: Laboratory studies report no activity of blessed thistle against herpes viruses, influenza, or poliovirus. Effects of blessed thistle (or chemicals in blessed thistle called lignans) against HIV are not clear. Human research of blessed thistle as a treatment for viral infections is lacking.
- Blessed thistle is generally considered to be safe when taken by mouth in recommended doses for short periods of time, with few reported side effects such as birth defects, bleeding, breathing problems, bruising, cancer of the nose or throat, increased production of stomach acid, itching, kidney disease, liver toxicity, skin rash, stomach discomfort, stomach ulcers, and vomiting. Allergic reactions to blessed thistle including rash may occur, as well as cross-sensitivity to mugwort and Echinacea. Cross-reactivity may also occur with bitter weed, blanket flower, Chrysanthemum, coltsfoot, daisy, dandelion, dwarf sunflower, goldenrod, marigold, prairie sage, ragweed or other plants in the Asteraceae/Compositae family. Avoid if pregnant or breastfeeding.
- Boxwood: Trials have been conducted for SPV30 (extract of boxwood, Arkopharma, France) to evaluate its potential effectiveness for HIV/AIDS. Rigorous clinical study is needed to confirm these early study results.
- Avoid if allergic or hypersensitive to boxwood, its constituents, or any plants in the Buxaceae family. Use cautiously with HIV or AIDS. Avoid if pregnant or breastfeeding.
- Carrageenan: Carrageenan-based gels may reduce HIV transmission during sexual intercourse and have been investigated for safety and acceptability in published studies involving healthy females. Overall, studies suggest that carrageenan is not associated with abnormal genital clinical findings or severe side effects, and is considered acceptable for use by females and their male partners. Additional research is needed to better determine the role of carrageenan for HIV infection prevention.
- Use oral carrageenan cautiously in infants. Use cautiously in patients with, or at risk for, cancer. Use cautiously in patients treated with azoxymethane or nitrosomethylurea. Use cautiously in patients with gastrointestinal, immune, inflammatory, or bleeding disorders, or in patients with low blood pressure or diabetes. Use cautiously intravaginally. Use cautiously in patients using antilipemic agents. Use cautiously in combination with any oral medication, as the fiber in carrageenan may impair the absorption of oral medications.
- Chiropractic: Chiropractic care focuses on how the relationship between musculoskeletal structure (mainly the spine) and bodily function (mainly nervous system) affects health. There is currently not enough reliable scientific evidence to conclude the effects of chiropractic techniques on CD4 cell count or quality of life in patients with HIV/AIDS.
- Use extra caution during cervical adjustments. Use cautiously with acute arthritis, conditions that cause decreased bone mineralization, brittle bone disease, bone softening conditions, bleeding disorders or migraines. Use cautiously with the risk of tumors or cancers. Avoid with symptoms of vertebrobasilar vascular insufficiency, aneurysms, unstable spondylolisthesis, or arthritis. Avoid with agents that increase the risk of bleeding. Avoid in areas of para-spinal tissue after surgery. Avoid if pregnant or breastfeeding due to a lack of scientific data.
- Coenzyme Q10:
Coenzyme Q10 (CoQ10) is produced by the body and it is necessary for basic functioning of cells. CoQ10 levels decrease with age. There is limited evidence that natural levels of CoQ10 in the body may be reduced in people with HIV/AIDS. Reliable scientific research showing that CoQ10 supplements have any effect on this disease is currently lacking.
- There are currently no documented cases of allergy associated with Coenzyme Q10 supplements, although rash and itching have rarely been reported. Stop use two weeks before surgery/dental/diagnostic procedures with bleeding risk and do not use immediately after these procedures. Use cautiously with history of blood clots, diabetes, high blood pressure, heart attack, or stroke. Use cautiously with anticoagulants (blood thinners), antiplatelet drugs, blood pressure drugs, blood sugar drugs, cholesterol drugs, or thyroid drugs. Avoid if pregnant or breastfeeding.
- Cranberry: Limited laboratory research has examined the antiviral activity of cranberry. Further research is warranted in this area.
- Avoid if allergic to cranberries, blueberries, or other plants of the Vaccinium species. Sweetened cranberry juice may affect blood sugar levels. Use cautiously with a history of kidney stones. Pregnant and breastfeeding women should avoid cranberry in higher amounts than what is typically found in foods.
DHEA (dehydroepiandrosterone) is a hormone that is secreted by the adrenal glands. Although some studies suggest that DHEA supplementation may be beneficial in patents with HIV, results from different studies do not agree with each other. There is currently not enough scientific evidence to recommend DHEA for AIDS, and other therapies are more proven in this area.
- Avoid if allergic to DHEA. Avoid with a history of seizures. Use cautiously with adrenal or thyroid disorders. Use cautiously if taking anticoagulants, or drugs, herbs, or supplements for diabetes, heart disease, seizures, or stroke. Stop use two weeks before surgery/dental/diagnostic procedures with bleeding risk, and do not use immediately after these procedures. Avoid if pregnant or breastfeeding.
- Flaxseed and flaxseed oil:
Flaxseed and flaxseed oil/linseed oil are rich sources of the essential fatty acid, alpha-linolenic acid (omega-6). While flaxseed has been used to treat HIV/AIDS, no strong evidence supports its use and no recommendation can be made without further research.
- Flaxseed has been well tolerated in studies for up to four months. Avoid if allergic to flaxseed, flaxseed oil, or other plants of the Linaceae family. Avoid with prostrate cancer, breast cancer, uterine cancer, or endometriosis. Avoid ingestion of immature flaxseed pods. Avoid large amounts of flaxseed by mouth and mix plenty of water or liquid. Avoid flaxseed (not flaxseed oil) with history of esophageal stricture, ileus, gastrointestinal stricture, or bowel obstruction. Avoid with history of acute or chronic diarrhea, irritable bowel syndrome (IBS), diverticulitis (inflammation of the diverticula, small sacs in the intestine's inner lining), or inflammatory bowel disease (IBD). Avoid topical flaxseed in open wounds or abraded skin surfaces. Use cautiously with history of a bleeding disorder or with drugs that increase the risk of bleeding (such as anticoagulants and non-steroidal anti-inflammatories). Use cautiously with high triglyceride levels, diabetes, mania, seizures, or asthma. Avoid if pregnant or breastfeeding.
- Healing Touch: Healing touch (HT) is a combination of hands-on and off-body techniques that influence the flow of energy through a person's biofield. Data from small preliminary studies are insufficient to support any recommendations for or against use of HT in HIV/AIDS patients. Studies of better design are needed before any conclusions can be reached.
- HT should not be regarded as a substitute for established medical treatments. Use cautiously if pregnant or breastfeeding.
- L-carnitine: L-carnitine may be beneficial in AIDS treatment by increasing proliferation of mononuclear cells and increasing CD4 counts. Additional study is needed to make a firm recommendation.
- Avoid if allergic or hypersensitive to carnitine. Use cautiously with peripheral vascular disease, high blood pressure, alcohol-induced liver cirrhosis, and diabetes. Use cautiously in low birth weight infants and individuals on hemodialysis. Use cautiously if taking anticoagulants (blood thinners), beta-blockers, or calcium channel blockers. Avoid if pregnant or breastfeeding.
- Licorice: Early studies suggest that glycyrrhizin may inhibit HIV replication in patients with AIDS. However, human reports are lacking. Additional study is needed to make a conclusion.
- Avoid with a known allergy to licorice, any component of licorice, or any member of the Fabaceae (Leguminosae) plant family. Avoid with congestive heart failure, coronary heart disease, kidney or liver disease, fluid retention, high blood pressure, hormonal abnormalities or with use of diuretics. Licorice can cause abnormally low testosterone levels in men or high prolactin or estrogen levels in women. This may make it difficult to become pregnant and may cause menstrual abnormalities.
- Massage: Evidence is limited and mixed as to whether massage may be of benefit for immune functioning or health services utilization in people with HIV/AIDS.
- Avoid with bleeding disorders, low platelet counts, or if on blood-thinning medications (such as heparin or warfarin/Coumadin®). Areas should not be massaged where there are fractures, weakened bones from osteoporosis or cancer, open/healing skin wounds, skin infections, recent surgery, or blood clots. Use cautiously with history of physical abuse or if pregnant or breastfeeding. Massage should not be used as a substitute for more proven therapies for medical conditions. Massage should not cause pain to the client.
- Meditation: Various forms of meditation have been practiced for thousands of years throughout the world, with many techniques originating in Eastern religious practices. A common goal is to attain a state of "thoughtless awareness" of sensations and mental activities occurring at the present moment. More studies are needed to establish how meditation may be useful as an adjunctive therapy in HIV/AIDS patients.
- Use cautiously with underlying mental illnesses. People with psychiatric disorders should consult with their primary mental healthcare professionals before starting a program of meditation and they should explore how meditation may or may not fit in with their current treatment plans. Avoid with risk of seizures. The practice of meditation should not delay the time to diagnosis or treatment with more proven techniques or therapies, and it should not be used as the sole approach to illnesses.
- Melatonin: Melatonin is a neurohormone produced in the brain. There is a lack of well-designed scientific evidence to recommend for or against the use of melatonin as a treatment for AIDS. Melatonin should not be used in place of more proven therapies, and patients with HIV/AIDS should be treated under the supervision of their healthcare professionals.
- Based on available studies and clinical use, melatonin is generally regarded as safe in recommended doses for short-term use. There are rare reports of allergic skin reactions after taking melatonin by mouth. Use cautiously with bleeding disorders, seizure disorders, or if taking drugs that increase the risk of bleeding.
- Mistletoe: Treatment of HIV patients with mistletoe has been conducted in Europe since the beginning of the AIDS epidemic. Treatment seems to be tolerable with minimal side effects reported. Mistletoe may assist in inhibiting disease progression. However, not all mistletoe preparations have shown equal effects. Further study is needed before a firm conclusion can be made.
- Avoid if allergic or hypersensitive to mistletoe or to any of its constituents. Anaphylactic reactions (life threatening, shock) have been described after injections of mistletoe. Avoid with acute, highly febrile, inflammatory disease, thyroid disorders, seizure disorders, or heart disease. Use cautiously with diabetes, glaucoma, or with cholinergics.
- Prayer/distant healing: Prayer can be defined as a "reverent petition," the act of asking for something while aiming to connect with God or another object of worship. Limited study of prayer in patients with HIV/AIDS reports fewer new AIDS-related illnesses and hospitalizations. However, due to methodological problems, these results cannot be considered conclusive.
- Prayer is not recommended as the sole treatment approach for potentially serious medical conditions, and it should not delay the time it takes to consult with a healthcare professional or receive established therapies. Sometimes religious beliefs come into conflict with standard medical approaches and require an open dialog between patients and caregivers.
- Psychotherapy: Psychotherapy is an interactive process between a person and a qualified mental health professional. The patient will explore thoughts, feelings, and behaviors to help with problem solving. Psychotherapy, especially supportive psychotherapy, may reduce depression in HIV-positive patients. It may also help with treating substance abuse when used in combination with prescription medicine. Supportive-expressive group therapy may also have concomitant improvements in CD4 cell count and viral load. More research is needed in this area, especially to determine the best type of psychotherapy.
- Psychotherapy cannot always fix mental or emotional conditions. Psychiatric drugs are sometimes needed. In some cases, symptoms may get worse if the proper medication is not taken. Not all therapists are qualified to work with all problems. Use cautiously with serious mental illness or some medical conditions because some forms of psychotherapy may stir up strong emotional feelings and expression.
- Reiki: Reiki instruction may help reduce pain or anxiety in HIV/AIDS patients, but results are unclear.
- Reiki is not recommended as the sole treatment approach for potentially serious medical conditions, and should not delay the time it takes to consult with a healthcare professional or receive established therapies. Use cautiously with psychiatric illnesses.
- Relaxation therapy: Relaxation techniques include behavioral therapeutic approaches that differ widely in philosophy, methodology, and practice. Mental health and quality-of-life improvements have been seen in preliminary studies of HIV/AIDS patients. These findings suggest the need for further, well-controlled research.
- Avoid with psychiatric disorders like schizophrenia/psychosis. Jacobson relaxation (flexing specific muscles, holding that position, then relaxing the muscles) should be used cautiously with illnesses like heart disease, high blood pressure, or musculoskeletal injury. Relaxation therapy is not recommended as the sole treatment approach for potentially serious medical conditions, and it should not delay the time to diagnosis or treatment with more proven techniques.
- Selenium: Selenium is a mineral found in soil, water, and some foods. Selenium supplementation has been studied in HIV/AIDS patients, and some reports associate low selenium levels with complications such as cardiomyopathy. It remains unclear if selenium supplementation is beneficial in patients with HIV, particularly during antiretroviral therapy.
- Avoid if allergic or sensitive to products containing selenium. Avoid with history of non-melanoma skin cancer. Selenium is generally regarded as safe for pregnant or breastfeeding women. However, animal research reports that large doses of selenium may lead to birth defects.
- Shiitake: Based on preliminary studies, lentinan from shiitake mushroom may increase CD4 counts and may be effective as an adjunct therapy in HIV. Further well-designed studies are needed to confirm these results. Side effects have been reported and more proven therapies are recommended at this time.
- Avoid if allergic or hypersensitive to shiitake mushrooms. Avoid if pregnant or breastfeeding.
- Sorrel: There is currently not enough evidence on the proposed antiviral effects of sorrel. More research is needed.
- Avoid large doses of sorrel because there have been reports of toxicity and death. This may be because of the oxalate found in sorrel. Many sorrel tinctures contain high levels of alcohol and should be avoided when driving or operating heavy machinery. These sorrel formulations may cause nausea or vomiting when taken with the prescription drugs metronidazole (Flagyl®) or disulfiram (Antabuse®). Avoid if pregnant or breastfeeding.
- Spiritual healing: Distant healing and prayer have been used in patients with HIV/AIDS. There is conflicting evidence in this area and more study is needed.
- Spiritual healing should not be used as the only treatment approach for medical or psychiatric conditions, and should not delay the time it takes to consider more proven therapies.
- Therapeutic touch: There is currently not enough evidence that therapeutic touch may benefit immunity or emotional well-being in HIV/AIDS patients. More research is needed.
- Avoid with fever or inflammation, and on areas of the body with cancer.
- Thymus extract: Thymus extracts for nutritional supplements are usually derived from young calves. Preliminary evidence found no improvement in HIV progression to AIDS or immunostimulation, although some immunological activity was noted in a non-randomized controlled trial. Additional study is needed to better understand the effects of thymus extract for HIV/AIDS.
- Avoid if allergic or hypersensitive to thymus extracts. Use bovine thymus extract supplements cautiously due to potential for exposure to the virus that causes "mad cow disease." Avoid use with an organ transplant or other forms of allografts or xenografts. Avoid if receiving immunosuppressive therapy or hormone therapy. Avoid with thymic tumors, myasthenia gravis (neuromuscular disorder), or untreated hypothyroidism. Avoid if pregnant or breastfeeding. Thymic extract increases human sperm motility and progression.
- Traditional Chinese medicine (TCM): Traditional Chinese medicine (TCM) is a broad term that refers to many different treatments and traditions of healing. They share a common heritage of technique or theory rooted in ancient Chinese philosophy (Taoism) that dates back over 5,000 years. TCM herbs are a popular complementary therapy in HIV/AIDS. However, study results conflict. More studies are needed before the potential benefits of TCM herbs in HIV/AIDS can be established.
- Chinese herbs can be potent and may interact with other herbs, foods, or drugs. Consult a qualified healthcare professional before taking. There have been reports of manufactured or processed Chinese herbal products being tainted with toxins or heavy metal or not containing the listed ingredients. Herbal products should be purchased from reliable sources. Avoid ma huang, which is the active ingredient in ephedra. Avoid ginseng if pregnant or breastfeeding.
- Turmeric: Turmeric is a perennial plant native to India and Indonesia, and it is often used as a spice in cooking. Based on early research, turmeric may help treat various viral infections. Several laboratory studies suggest that curcumin, a component of turmeric, may have activity against HIV/AIDS. However, reliable human studies are lacking in this area.
Well-designed trials are needed.
- Avoid if allergic or hypersensitive to turmeric (curcumin), yellow food colorings, or plants belonging to the Curcuma or Zingiberaceae (ginger) families. Use cautiously with a history of bleeding disorders, immune system deficiencies, liver disease, or gallstones. Use cautiously with blood thinners (e.g. warfarin). Use cautiously if pregnant or breastfeeding.
- Vitamin A: Vitamin A is a fat-soluble vitamin that is derived from two sources:
retinoids and carotenoids. Retinoids are found in animal sources (such as the liver, kidney, eggs, and dairy products). Carotenoids are found in plants like dark or yellow vegetables and carrots. The role of vitamin A in the prevention, transmission, or treatment of HIV infection is controversial and not well established. A clear conclusion cannot be formed based on the available scientific research.
- Avoid if allergic or hypersensitive to vitamin A. Vitamin A toxicity can occur if taken at high dosages. Use cautiously with liver disease or alcoholism. Smokers who consume alcohol and beta-carotene may have an increased risk for lung cancer or heart disease. Vitamin A appears safe in pregnant women if taken at recommended doses. Use cautiously if breastfeeding because the benefits or dangers to nursing infants are not clearly established.
Patients with HIV/AIDS, especially those with low zinc levels, may benefit from zinc supplementation. Some low quality studies cite reduction in infections, enhanced weight gain, and immune system function, including increased CD4 and CD8 cells, with use of zinc. However, other low quality studies conflict with these findings. Further research is needed before a conclusion can be made.
- Zinc is generally considered safe when taken at the recommended dosages. Avoid zinc chloride since studies have not been done on its safety or effectiveness. While zinc appears safe during pregnancy in amounts lower than the established upper intake level, caution should be used since studies cannot rule out the possibility of harm to the fetus.
- Fair negative scientific evidence:
- Ozone therapy: Ozone molecules are composed of three oxygen atoms. Ozone exists high in the earth's atmosphere and absorbs radiation from the sun. Reports of using ozone for medicinal purposes date to the late 19th Century. Laboratory studies have shown the HIV virus to be sensitive to ozone, but high-quality human studies are lacking. A preliminary study measured the safety and effectiveness of ozone-treated blood in the treatment of HIV infection and immune disease. Ozone therapy was not shown to enhance immune activation or diminish the HIV virus.
- Autohemotherapy (a therapy in which blood is withdrawn from the body) infused with ozone, and then replaced into the body), has been associated with transmission of viral hepatitis and with a possible case of dangerously lowered blood cell counts. Insufflation of the ear carries a risk of tympanic membrane ("ear drum") damage, and colon insufflation may increase the risk of bowel rupture. Consult a qualified health professional before undergoing any ozone-related treatment.
- St John's wort:
Anti-viral effects of St. John's wort have been observed in laboratory studies, but were not found in available human study. Multiple reports of significant adverse effects and interactions with drugs used for HIV/AIDS, including protease inhibitors (PIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs), suggest that patients being treated for HIV/AIDS should avoid this herb. Therefore, there is evidence to recommend against using St. John's wort in the treatment of patients with HIV/AIDS.
- Avoid if allergic or hypersensitive to plants in the Hypericaceaefamily. Rare allergic skin reactions like itchy rash have been reported. Avoid with immunosuppressant drugs (such as cyclosporine, tacrolimus, or myophenic acid). Avoid with non-nucleoside reverse transcriptase inhibitors or protease inhibitors. Avoid with organ transplants, suicidal symptoms, or before surgery. Use cautiously with history of thyroid disorders. Use cautiously with drugs that are broken down by the liver, with monoamine oxidase inhibitors (MAOI) or selective serotonin reuptake inhibitors (SSRIS), digoxin, or birth control pills. Use cautiously with diabetes or with history of mania, hypomania, or seasonal affective disorder (SAD). Avoid if pregnant or breastfeeding.
Suggested benefits of treatment interruptions
- General: Researchers hoped structured treatment interruptions in antiretroviral therapy (ART) might help treat drug resistance and reduce side effects and cost. However, research has shown that there are many serious health risks associated with treatment interruptions, and the potential risks generally do not outweigh the benefits.
- Drug resistance: In the past, some healthcare providers recommended discontinuing antiretroviral therapy (ART) for a period of time if the patient became resistant to medications. Mutations (changes in the genetic makeup) occur almost every time a new copy of the virus is produced. Some of the mutated HIV strains are resistant to antiretroviral drugs. When this happens, the drug is no longer effective against HIV, even if it is taken in the future.
- If the patient stops taking the medication he/she is resistant to, the normal form of the virus will multiply faster than the mutated form. Then, the normal form can be controlled with medications. However, it has since been determined that patients should not discontinue all antiretrovirals while waiting for the normal type of HIV to dominate the mutated form. Instead, patients should only discontinue the medication they are resistant to and they should continue to take the other antiretrovirals prescribed to them.
- Reduced cost: ART is expensive, particularly for patients who do not have health insurance. Without insurance, ART costs an average of $20-25,000 a year in the United States. Researchers hoped that breaks in treatment would help decrease this financial burden.
- Reduce side effects: It had been suggested that starting and stopping antiretroviral therapy in cycles might help reduce some of the side effects of treatment. Side effects of antiretrovirals vary depending on the specific drug regimen. In general, some of the most common side effects of antiretrovirals include dizziness, confusion, fatigue, headache, difficulty sleeping, nausea, vomiting, and diarrhea.
- Dealing with health problems: Long-term side effects of continual antiretroviral therapy may cause serious medical problems, including liver problems and changes in metabolism, such as abnormal lipid and glucose metabolism. These conditions may lead to changes in body fat distribution or the onset or worsening of diabetes. In some cases, patients can take different medications. However, if the patient has already taken most antiretrovirals, they may need to stop taking medication temporarily until they recover from the side effects.
- It has not been determined whether the potential health benefits outweigh the risks of this type of treatment. Patients who experience severe side effects from treatment should consult their healthcare providers to determine the safest and most effective treatment.
Reported risks of treatment interruptions
- Decline in immune function/Increased risk of infection: When antiretroviral therapy (ART) is stopped, the amount of HIV in the blood, called the viral load, increases dramatically. A low viral load is about 200-500 copies per milliliter of blood. A high viral load can be anywhere from 5,000-1,000,000 or more copies. A high viral load indicates that HIV is replicating and the disease will most likely progress quicker than if the viral load is low.
- The increased viral load leads to a decline in CD4 cells. This is because HIV primarily infects the CD4 cells, which are white blood cells that help coordinate the immune system's response to infections and diseases. Healthy individuals have a CD4 cell count between 600 and 1,200 cells per microliter of blood. HIV patients have less than 600 CD4 cell counts per microliter of blood. Patients progress to AIDS (acquired immune deficiency syndrome) when their CD4 cell counts drop below 200 cells per microliter of blood. When CD4 counts are this low, there is a high risk of developing serious, sometimes deadly infections.
- Research has shown that patients who stopped ART had an increased risk of developing opportunistic infections. Opportunistic infections occur in individuals who have weakened immune systems. The organisms (bacteria, fungi, or viruses) that cause these infections do not cause illnesses in patients who have healthy immune systems because healthy patients are able to fight off the infection.
- HIV and AIDS patients are vulnerable to opportunistic infections, such as Pneumocystis jiroveci pneumonia (formerly called Pneumocystis carinii pneumonia or PCP), mycobacterium avium complex (MAC), toxoplasmosis, and tuberculosis. Certain infections are considered AIDS-defining illnesses. This means that when HIV-infected patients develop the infection, their condition has progressed to AIDS. Patients who had low CD4 cell counts before stopping treatment have the greatest risk of experiencing these infections.
- Also, when ART is discontinued, patients may develop flu-like symptoms, which most patients experience when they first become infected with the virus. This is because the virus is actively multiplying in the body. Symptoms may include fatigue, enlarged lymph nodes, sore throat, fever, and fatigue.
- Once ART is restarted, the amount of HIV in the blood decreases, and the CD4 counts increase. However, these levels may not return to levels achieved before the interruption, and the risk of infection may remain higher than before treatment was stopped.
- Drug resistance: Stopping and restarting ART increases the likelihood that the virus will become resistant to medications. Research has shown that in order for anti-HIV drugs to work correctly, they must be taken exactly as prescribed. Taking breaks in treatment can cause the amount of an antiretroviral drug to decrease in the bloodstream. If the drug level becomes too low, HIV can begin reproducing at a more rapid rate. The faster HIV reproduces, the more mutations occur, including those that may be resistant to drugs.
- According to several studies, HIV patients must be more than 95% adherent to their treatment plans in order for the drugs to remain effective. In other words, missing more than one dose a month can reduce the drug's effectiveness. Healthcare providers evaluate the effectiveness of treatment by measuring the patient's CD4 cell count. If the CD4 cell count is maintained, the likelihood of virus mutating into a resistant strain is reduced.
- Resurgence of side effects:
When patients continually take antiretrovirals, many side effects of treatment gradually lessen over time. However, when therapy is discontinued for a period of time and then restarted, patients are more likely to experience a resurgence of initial side effects, such as dizziness, confusion, fatigue, headache, difficulty sleeping, nausea, vomiting, and diarrhea.
- Superinfection: According to studies, there have been cases of patients becoming superinfected, or re-infected, with a different strain (type) of HIV while they are taking a break from treatment. This is because low or nonexistent levels of antiretrovirals in the bloodstream allow HIV to reproduce rapidly. The faster HIV multiplies, the more mutations occur.
- General: Two types of cycling have been studied. The first type of cycling was based on the patients' CD4 cells counts and/or viral loads. When levels were adequate, therapy was stopped and when CD4 counts decreased and HIV loads increased, patients were restarted on therapy. The second study was based on a fixed schedule. Patients stopped and started treatment after a certain number of days. Both studies compared intermittent drug therapy with continuous therapy.
- Strategies for the Management of Antiretroviral Therapy (SMART) trial: Researchers of the Strategies for the Management of Antiretroviral Therapy (SMART) trial set out to determine whether antiretroviral therapy (ART) could be used only when needed, instead of continuously. Before the study began, it had been suggested that patients who began ART soon after diagnosis were able to safely interrupt treatment.
- The study, which began in 2002, included 5,472 participants from 33 countries making it the largest treatment strategy trial ever conducted. Participants received ART when their CD4 counts dropped below 250 cells per microliter of blood. Treatment was stopped when their cell count increased to 350 CD4 cells per microliter of blood.
- In January 2006, SMART's Data and Safety Monitoring Board (DSMB) recommended that the trial end early because nearly twice the number of the participants in the intermittent therapy group progressed to AIDS, compared to the group receiving continuous therapy. Also, several participants in the intermittent therapy group died, and many others experienced serious complications associated with drug toxicity. Investigators of the study agreed with the DSMB and advised all participants to restart ART.
- Development of Anti-Retroviral Therapy in Africa (DART): Soon after the SMART study ended, the treatment interruption group of another study titled, Development of Anti-Retroviral Therapy in Africa (DART), also ended early. In this study, patients who had a CD4 cell count of 300 or higher were randomized to receive either continuous ART or 12-week cycles of antiretrovirals, followed by a 12-week break.
- However, researchers of the DART study noted similar results to the SMART study. According to the researchers, patients who received intermittent ART were more likely to develop HIV-related illnesses and AIDS-defining illnesses than patients who received continuous therapy. Patients in the treatment interruption group were advised to restart continuous ART. The researchers concluded that 12-week cycles of antiretroviral therapy, followed by 12-week breaks in treatment, were unsafe for patients who started treatment with a CD4 cell count lower than 200 cells per microliter of blood or for patients with a history of HIV-related illnesses.
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The information in this monograph is intended for informational purposes only, and is meant to help users better understand health concerns. Information is based on review of scientific research data, historical practice patterns, and clinical experience. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions.