A Study of Different Doses of Megestrol Acetate in Patients With AIDS Who Have Anorexia and Malnutrition

Phase 2

Completed

• Conditions: Anorexia; Cachexia; HIV Infections

• Registration Number: NCT00002300
• 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 characterize dose response in relation to weight gain. 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 (15)

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

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

Dr Stephen J Gabin Jr; 🇺🇸 Los Angeles, California, United States

Birmingham Veterans Administration Med Ctr / Univ of Alabama; 🇺🇸 Birmingham, Alabama, United States

Albany Med College / AIDS Treatment Ctr; 🇺🇸 Albany, New York, United States

Dr NS Tchekmedyian; 🇺🇸 Long Beach, California, United States

Audie L Murphy Veterans Administration Hosp; 🇺🇸 San Antonio, Texas, United States

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

Community Research Initiative on AIDS; 🇺🇸 New York, New York, United States

Saint Vincent's Hosp and Med Ctr; 🇺🇸 New York, New York, United States

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

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

Veterans Administration Med Ctr; 🇺🇸 Washington, District of Columbia, United States

Univ of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

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