The Safety and Effectiveness of Megace in HIV-Infected Women

HIV Infections Clinical Trial

Official title:

Phase IV Study on the Safety and Efficacy of Megace Oral Suspension in HIV-Positive Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002345
• Other study ID #: 025C
• Secondary ID: MEG169-93.007
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: October 1, 2007

Study information

• Verified date: October 2007
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Cachexia
• HIV Infections

Intervention

Drug:
• Megestrol acetate

Locations

Country	Name	City	State
United States	Yale Univ Med School	New Haven	Connecticut
United States	Miriam Hosp	Providence	Rhode Island
United States	Univ of California - Davis Med Ctr / CARES	Sacramento	California
United States	Georgetown Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm