The Safety and Effectiveness of Megace in HIV-Infected Women

NCT ID: NCT00002345

Last Updated: 2007-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL

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.

Conditions

Anorexia; Cachexia; HIV Infections

Keywords

Megestrol; Acquired Immunodeficiency Syndrome; Anorexia; Cachexia; Suspensions

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

Megestrol acetate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.
• Previous abnormal mammogram (if 35-40 years of age) or abnormal mammogram within the past year (if over 40 years of age).

Prior Medication:

Excluded:

• New antiviral therapy within the past 8 weeks.
• Medications to promote weight gain (e.g., corticosteroid, dronabinol) within the past 2 months.
• Megestrol acetate within the past 3 months. IV drug abuse not treated for at least 4 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Locations

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 D.C., District of Columbia, United States

Miriam Hosp

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

MEG169-93.007

Identifier Type: -

Identifier Source: secondary_id

025C

Identifier Type: -

Identifier Source: org_study_id