A Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia

Phase 3

Completed

• Conditions: Cachexia; HIV Infections; Anorexia

• Registration Number: NCT00002067
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

To compare the effects of megestrol acetate and placebo on body weight, anorexia, cachexia, calorie intake, and nutritional parameters of patients with a confirmed diagnosis of AIDS. To determine whether megestrol acetate relative to placebo improves the perception of well-being among AIDS patients with cachexia. To evaluate megestrol acetate's effect on immune function via skin test reactivity, T4/T8 ratio, and total lymphocytes.

Detailed Description

Not available

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: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (14)

Dr Mark Goldstein; 🇺🇸 Los Angeles, California, United States

Eisenhower Med Ctr; 🇺🇸 Rancho Mirage, California, United States

Northwestern Univ Med School; 🇺🇸 Chicago, Illinois, United States

Northwest Family Ctr at the Harbor View Med Ctr; 🇺🇸 Seattle, Washington, United States

Palo Alto Veterans Adm Med Ctr / Stanford Univ; 🇺🇸 Palo Alto, California, United States

UCD Med Ctr; 🇺🇸 Sacramento, California, United States

Summitt Med Ctr / San Francisco Gen Hosp; 🇺🇸 Oakland, California, United States

Miami Veterans Administration Med Ctr; 🇺🇸 Miami, Florida, United States

SUNY / Health Sciences Ctr at Syracuse; 🇺🇸 Syracuse, New York, United States

Mem Sloan - Kettering Cancer Ctr; 🇺🇸 New York, New York, United States

San Francisco AIDS Clinic / San Francisco Gen Hosp; 🇺🇸 San Francisco, California, United States

San Francisco Veterans Administration Med Ctr; 🇺🇸 San Francisco, California, United States

Denver Public Health Dept; 🇺🇸 Denver, Colorado, United States

Univ of South Florida; 🇺🇸 Tampa, Florida, United States