The Safety and Effectiveness of Megace in HIV-Infected Women

Phase 4

Completed

• Conditions: Anorexia; Cachexia; HIV 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.

Study Timeline

• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-01
• Last Update Posted: 2007-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

Yale Univ Med School; 🇺🇸 New Haven, Connecticut, United States

Georgetown Univ Med Ctr; 🇺🇸 Washington, District of Columbia, United States

Univ of California - Davis Med Ctr / CARES; 🇺🇸 Sacramento, California, United States

Miriam Hosp; 🇺🇸 Providence, Rhode Island, United States