The Safety and Effectiveness of Megace in HIV-Infected Women

NCT00002345 | Completed Phase 4

• 2 other identifiers: 025CMEG169-93.007
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

Anorexia; Cachexia; HIV Infections

Keywords

Megestrol; Acquired Immunodeficiency Syndrome; Anorexia; Cachexia; Suspensions

Interventions

Megestrol acetate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have:
• HIV infection.
• Evidence of HIV wasting syndrome that includes anorexia (appetite fair or poor) and weight loss \>= 10 percent of pre-illness body weight.
• Perception of weight loss as a detriment.
• Life expectancy of at least 24 weeks.
• Prior Medication:
• Allowed:
• Megestrol acetate for weight gain at a dose \< 400 mg for \< 60 days, provided therapy was discontinued at least 3 months prior to study entry.

You may not qualify if:

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Poorly controlled hypertension.
• Heart failure.
• Deep vein thrombosis.
• Uncontrolled severe diarrhea.
• Treatable active current infection (excluding chronic low-grade opportunistic infections).
• Unable to intake food.
• Impaired digestive/absorptive function.
• Concurrent Medication:
• Excluded:
• Initiation during the study of any therapy to treat HIV or anorexia/cachexia (other than study drug).
• Patients with the following prior conditions are excluded:
• Hospitalization for or exacerbation of illness associated with weight loss within the past 2 weeks.
• Participation in other investigational drug studies within the past month.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (4)

Univ of California - Davis Med Ctr / CARES

Sacramento, California, 95817, United States

Location

Yale Univ Med School

New Haven, Connecticut, 065102483, United States

Location

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, 200072197, United States

Location

Miriam Hosp

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Anorexia; Cachexia; HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Megestrol Acetate

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Thinness; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: October 2, 2007

Record last verified: 2007-10

Locations

US (4)