The Safety and Effectiveness of Megace in HIV-Infected Women
- Conditions
- AnorexiaCachexiaHIV Infections
- Registration Number
- NCT00002345
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Univ of California - Davis Med Ctr / CARES
🇺🇸Sacramento, California, United States
Yale Univ Med School
🇺🇸New Haven, Connecticut, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Miriam Hosp
🇺🇸Providence, Rhode Island, United States
Univ of California - Davis Med Ctr / CARES🇺🇸Sacramento, California, United States