A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss
Public ClinicalTrials.gov record NCT00001079. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00001079
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 80 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Nov 30, 2002
- Last update posted
- Oct 31, 2021
Ends 2002
United States locations
- U.S. sites
- 21
- U.S. states
- 14
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| USC CRS | Los Angeles | California | 90033 | — |
| UCLA CARE Center CRS | Los Angeles | California | 90035 | — |
| Ucsf Aids Crs | San Francisco | California | 94110 | — |
| University of Colorado Hospital CRS | Aurora | Colorado | 80045 | — |
| Howard University Hosp., Div. of Infectious Diseases, ACTU | Washington D.C. | District of Columbia | 20060 | — |
| Queens Med. Ctr. | Honolulu | Hawaii | 96813 | — |
| Univ. of Hawaii at Manoa, Leahi Hosp. | Honolulu | Hawaii | 96816 | — |
| Northwestern University CRS | Chicago | Illinois | 60611 | — |
| Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis | Indiana | 46202 | — |
| Indiana Univ. School of Medicine, Wishard Memorial | Indianapolis | Indiana | 46202 | — |
| Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU | New Orleans | Louisiana | 70112 | — |
| Johns Hopkins Adult AIDS CRS | Baltimore | Maryland | 21287 | — |
| Beth Israel Deaconess Med. Ctr., ACTG CRS | Boston | Massachusetts | 02215 | — |
| St. Louis ConnectCare, Infectious Diseases Clinic | St Louis | Missouri | — | — |
| Washington U CRS | St Louis | Missouri | — | — |
| Beth Israel Med. Ctr. (Mt. Sinai) | New York | New York | 10003 | — |
| Cornell University A2201 | New York | New York | 10021 | — |
| Memorial Sloan-Kettering Cancer Ctr. | New York | New York | 10021 | — |
| Duke Univ. Med. Ctr. Adult CRS | Durham | North Carolina | 27710 | — |
| Univ. of Cincinnati CRS | Cincinnati | Ohio | — | — |
| Hosp. of the Univ. of Pennsylvania CRS | Philadelphia | Pennsylvania | 19104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00001079, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 31, 2021 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00001079 live on ClinicalTrials.gov.