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A Study of Megestrol Acetate Alone or in Combination with Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on A Study of Megestrol Acetate Alone or in Combination with Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study of Megestrol Acetate Alone or in Combination with Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss Clinical research trials and A Study of Megestrol Acetate Alone or in Combination with Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including A Study of Megestrol Acetate Alone or in Combination with Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss. A Study of Megestrol Acetate Alone or in Combination with Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Study of Megestrol Acetate Alone or in Combination with Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss clinical trial. Participants oftentimes recieve the finest healthcare available for their A Study of Megestrol Acetate Alone or in Combination with Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of Megestrol Acetate Alone or in Combination with Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss  A Study of Megestrol Acetate Alone or in Combination with Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss
A Study of Megestrol Acetate Alone or in Combination with Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss
For Condition: HIV Infections,HIV Wasting Syndrome
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To test the hypothesis that the predominant accrual of fat rather than lean body mass (LBM) that occurs during treatment of HIV-associated wasting with megestrol acetate may be improved by treatment with megestrol acetate and testosterone enanthate in combination. Body wasting is an increasingly frequent AIDS-defining condition in individuals infected with HIV. Increasing caloric intake fails to consistently restore lean tissue patients with HIV associated weight loss. Megestrol acetate has been shown to stimulate appetite and weight gain in subjects with cancer and in those with HIV associated weight loss. However, the weight gained during treatment with megestrol acetate was predominantly or exclusively fat. An important factor is the preferential increase in body fat seen in both of these studies may have been due to hypogonadism that occurs as a result of treatment with megestrol acetate, a progestational agent. Hypogonadism is associated with an increase in body fat and a decrease in LBM. Concomitant testosterone replacement should substantially increase the amount of LBM accrued during megestrol acetate therapy. This study will determine whether anabolic potential can be realized when caloric intake is increased in the absence of concomitant hypogonadism.
Details: Body wasting is an increasingly frequent AIDS-defining condition in individuals infected with HIV. Increasing caloric intake fails to consistently restore lean tissue patients with HIV associated weight loss. Megestrol acetate has been shown to stimulate appetite and weight gain in subjects with cancer and in those with HIV associated weight loss. However, the weight gained during treatment with megestrol acetate was predominantly or exclusively fat. An important factor is the preferential increase in body fat seen in both of these studies may have been due to hypogonadism that occurs as a result of treatment with megestrol acetate, a progestational agent. Hypogonadism is associated with an increase in body fat and a decrease in LBM. Concomitant testosterone replacement should substantially increase the amount of LBM accrued during megestrol acetate therapy. This study will determine whether anabolic potential can be realized when caloric intake is increased in the absence of concomitant hypogonadism. This is a 24 week study consisting of a 12 week double blind, randomized comparison Phase II trial of megestrol acetate and testosterone enanthate in combination versus megestrol acetate plus testosterone enanthate placebo in HIV associated wasting and a 12 week open label follow up of the combination therapy.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Stable antiretroviral therapy provided the patient has been on it for >=30 days prior to study entry. AS PER AMENDMENT 9/26/97: Optimized antiretroviral therapy as determined by primary care provider with at least 30 days since initiation of such therapy. - Standard maintenance and prophylaxis therapy for opportunistic infections is permitted provided patients have been on a stable dosage regimen for 2 weeks prior to screening. - G-CSF. - Erythropoietin. - Any symptomatic therapy (e.g., analgesics, antihistamines, antiemetic, antidiarrheal agents, etc.). - Replacement levels of thyroid drugs (same drug and dose as at 30 days pre-entry). - Maintenance therapy is permitted for chronic opportunistic infections, but patient must be on a stable regimen for 14 days pre-entry. - AS PER AMENDMENT 9/26/97: Oral nutritional supplements, dronabinol, cyproheptadine, or pentoxifylline. Patients must have: - Documented HIV-1 infection. - Documented weight loss of > 10% pre-illness weight or Body Mass Index < 18.5 kg/m2. AS PER AMENDMENT 9/26/97: Documented weight loss of >= 5% pre-illness weight or Body Mass Index < 20 kg/m2. - Life expectancy of at least 6 months. NOTE: - This protocol meets federal requirements governing prisoner participation in clinical trials. Prior Medication: Allowed: - Stable (no change in drugs or dosage) antiretroviral therapy or no antiretroviral medications for >= 30 days prior to the study entry. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: - Diabetes mellitus. - Diarrhea defined as 4 or more liquid or watery stools per day while using antidiarrheal medication. - Tube feeding. AS PER AMENDMENT 9/26/97: Total or partial parenteral nutrition delivered centrally or peripherally. - Impaired oral intake due to mucositis of any cause. - Grade 2 or greater intractable nausea and vomiting despite medication. - Cardiomyopathy or congestive heart failure. - Persistent palpable dominant breast mass at study entry that has not been worked up - males and females. Female patients: - Pap smear or cervical biopsy that demonstrates high grade squamous intraepithelial lesions or cervical intraepithelial lesions 2 or worse. Concurrent Medication: Excluded: - Systemic chemotherapy for B-cell lymphoma or malignancies other than Kaposi's sarcoma. (Patients with Kaposi's sarcoma receiving systemic chemotherapy will not be excluded.) - Total or peripheral parenteral nutrition (oral supplements are not excluded). - Anticoagulant therapy. - Any drug that is designed to affect appetite or weight gain. AS PER AMENDMENT 9/26/97: Initiation of any new therapy designed to promote weight gain. - Any change of antiretroviral or any change in the dosage of antiretroviral/s that had not been started 30 days pre-entry. AS PER AMENDMENT 9/26/97: Initiation of antiretroviral therapy within 12 weeks of protocol therapy for patients not previously receiving antiretroviral therapy. - Anabolic hormones. - Systemic glucocorticoids. - Cytokine inhibitors. - Oral contraceptives. - Cytokines. - Ketoconazole. - Any other medication that might interfere with the objectives of this study. - AS PER AMENDMENT 9/26/97:DHEA. Patients with the following prior conditions will be excluded: - Acute systemic opportunistic infections within 30 days prior to entry. - Weight gain >= 3% as documented by self reporting or clinical records during the preceding 4 weeks. AS PER AMENDMENT 9/26/97: Enrollment of such patients should be deferred until weight stabilizes. - History of hypersensitivity reaction to megestrol acetate or testosterone enanthate. - History of cardiomyopathy or congestive heart failure. Female patients: - History of invasive cervical cancer. - AS PER AMENDMENT 9/26/97: History of thromboemboli. Prior Medication: Excluded: - No testosterone treatment within the previous 8 weeks. Excluded within 30 days prior to entry: - Ketoconazole. - Initiation or change in antiretroviral therapy. - Interleukins. - Interferon, anabolic, hormonal or experimental therapies designed to improve appetite or weight gain (e.g., thalidomide, dronabinol, megestrol acetate, cyproheptadine, anabolic steroids, systemic glucocorticoids, pentoxifylline, or growth hormone). - AS PER AMENDMENT 9/26/97: Dehydroepiandrosterone (DHEA).
Total Enrollment: 80
Location and Contact Information:
Overall Study Official:
SchambelanM, Study Chair,
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Howard Univ
Washington D.C., District of Columbia, 20059
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Additional Information:
Study ID Numbers: ACTG 313;
Study Start Date:
Record last reviewed: June 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001079
Other Hiv Infections Studies:
1. A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects
2. The Safety of Zidovudine Plus Interferon-Alpha in HIV-Infected Children
3. A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
4. A Pilot Study of 566C80 for the Salvage Treatment of Toxoplasmic Encephalitis in Patients Infected With the Human Immunodeficiency Virus (HIV) Who Have Failed or are Intolerant of Pyrimethamine-Sulfadiazine
5. Antihyperlipidemic Effects of Oyster Mushrooms
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A Study of Megestrol Acetate Alone or in Combination with Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss
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