Trials / Completed
CompletedNCT00002345
The Safety and Effectiveness of Megace in HIV-Infected Women
Phase IV Study on the Safety and Efficacy of Megace Oral Suspension in HIV-Positive Females
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (planned)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To further evaluate the safety of megestrol acetate (Megace) oral suspension in the treatment of anorexia and cachexia in HIV-positive women. To compare the effectiveness of 2 doses of Megace by measurement of weight gain, appetite grade, and other parameters at 12 and 24 weeks.
Detailed description
Patients are randomized to receive 1 of 2 doses of Megace oral suspension daily for 24 weeks; at 12 weeks, those receiving the lower dose who have not gained 5 pounds over baseline or had appetite improvement to good or excellent are escalated to the higher dose. Patients are evaluated at 4-week intervals. Dose may be adjusted to maintain a desired weight.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Megestrol acetate |
Timeline
- First posted
- 2001-08-31
- Last updated
- 2007-10-02
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00002345. Inclusion in this directory is not an endorsement.