A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss
Double-Blind Randomized Comparison Phase II Trial of Megestrol Acetate and Testosterone Enanthate in Combination Versus Megestrol Acetate Plus Testosterone Enanthate Placebo in Human Immunodeficiency Virus (HIV)-Associated Wasting.
2 other identifiers
interventional
80
1 country
21
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2002
CompletedNovember 1, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- +4 more criteria
You may not qualify if:
- 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).
- +28 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
USC CRS
Los Angeles, California, 90033, United States
UCLA CARE Center CRS
Los Angeles, California, 90035, United States
Ucsf Aids Crs
San Francisco, California, 94110, United States
University of Colorado Hospital CRS
Aurora, Colorado, 80045, United States
Howard University Hosp., Div. of Infectious Diseases, ACTU
Washington D.C., District of Columbia, 20060, United States
Queens Med. Ctr.
Honolulu, Hawaii, 96813, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202, United States
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, 46202, United States
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, 70112, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States
Washington U CRS
St Louis, Missouri, United States
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, 10003, United States
Cornell University A2201
New York, New York, 10021, United States
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, 10021, United States
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, 27710, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
Schambelan M, Zackin R, Mulligan K, Sattler FR, Chesney M, Stevens M, Edwards L, Egorin MJ, Von Roenn JH. Effect of testosterone (T) on the response to megesterol acetate (MA) in patients with HIV-associated wasting: a randomized, double-blind placebo-controlled trial (ACTG 313). 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 640)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Schambelan M
- STUDY CHAIR
Mulligan K
- STUDY CHAIR
Von Roenn JH
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
December 1, 2002
Last Updated
November 1, 2021
Record last verified: 2021-10