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

HIV Infections Clinical Trial

Official title:

Phase II-III Randomized Double-Blind Study Comparing Megestrol Acetate at 100, 400, and 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002300
• Other study ID #: 025A
• Secondary ID: MEG8807
• Status: Completed
• Phase: Phase 2
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Patient must have:

• Confirmed diagnosis of AIDS (CDC definition).

• Documented weight loss or anorexia.

• Life expectancy = or > 20 weeks.

• The perception that the weight loss is a detriment to their well-being.

• Ability to provide informed consent, read and write English.

Prior Medication:

Allowed:

• Ganciclovir.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

• Dementia or evidence of mental incompetence which would preclude compliance with the protocol.

• Diarrhea defined as 5 or more watery stools per day for at least 7 days.

• Active uncontrolled systemic infections at the start of treatment.

• (Patients may not be entered for at least 2 weeks after acute infection.) Clinical or radiologic evidence of ascites or pleural effusions.

Concurrent Medication:

Excluded:

• Therapy designed to treat the underlying HIV infection or which may have a major impact on appetite and/or weight gain.

• Patients who have been started on zidovudine (AZT) within eight weeks. (Patients may have been previously treated with AZT and failed or may currently be receiving AZT for at least 8 weeks.)

Patients with the following are excluded:

• Obstruction to food intake or impaired digestive/absorptive functions.

• Contraindications to high-dose megestrol acetate (poorly controlled hypertension or heart failure or deep vein thrombosis).

• Inability to consent or be available for close follow-up.

• Active systemic infections at the start of treatment.

• Patients may not be started on any therapy designed to treat the underlying HIV infection or which may have a major impact on appetite and/or weight gain.

• Clinical or radiologic evidence of ascites or pleural effusions.

• Patients may not be started on any therapy designed to treat the underlying HIV infection or which may have a major impact on appetite and/or weight gain.

• Patients who have been hospitalized or have suffered an exacerbation of their illness associated with weight loss within the past 2 weeks are excluded.

• Menstruating female patients are excluded.

Prior Medication:

Excluded:

• Corticosteroids.

• Anabolic steroids.

• Marijuana.

• Megestrol acetate.

• Patients who have been started on zidovudine (AZT) within 8 weeks. (Patients may have been previously treated with AZT and failed or may currently be receiving AZT for at least 8 weeks.) History of substance abuse and questionable current and future abstinence.

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Cachexia
• HIV Infections

Intervention

Drug:
• Megestrol acetate

Locations

Country	Name	City	State
United States	Albany Med College / AIDS Treatment Ctr	Albany	New York
United States	Birmingham Veterans Administration Med Ctr / Univ of Alabama	Birmingham	Alabama
United States	Northwestern Univ Med School	Chicago	Illinois
United States	Denver Public Health Dept	Denver	Colorado
United States	Dr NS Tchekmedyian	Long Beach	California
United States	Dr Stephen J Gabin Jr	Los Angeles	California
United States	Miami Veterans Administration Med Ctr	Miami	Florida
United States	Community Research Initiative on AIDS	New York	New York
United States	Mem Sloan - Kettering Cancer Ctr	New York	New York
United States	Saint Vincent's Hosp and Med Ctr	New York	New York
United States	Univ of Pennsylvania	Philadelphia	Pennsylvania
United States	Eisenhower Med Ctr	Rancho Mirage	California
United States	Audie L Murphy Veterans Administration Hosp	San Antonio	Texas
United States	George Washington Univ Med Ctr	Washington	District of Columbia
United States	Veterans Administration Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

References & Publications (1)

Strang P. The effect of megestrol acetate on anorexia, weight loss and cachexia in cancer and AIDS patients (review). Anticancer Res. 1997 Jan-Feb;17(1B):657-62. Review. — View Citation

External Links

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