A Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00002067

Collaborator

(none)

Locations

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Cachexia HIV Infections	Drug: Megestrol acetate	Phase 3

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

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

Patients with the following are excluded:

Obstruction to food intake or impaired digestive/absorptive functions.
Contraindications to 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.
Clinical or radiologic evidence of ascites or pleural effusions.
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.)

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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr Mark Goldstein	Los Angeles	California	United States	90048
2	Summitt Med Ctr / San Francisco Gen Hosp	Oakland	California	United States	94609
3	Palo Alto Veterans Adm Med Ctr / Stanford Univ	Palo Alto	California	United States	94304
4	Eisenhower Med Ctr	Rancho Mirage	California	United States	92270
5	UCD Med Ctr	Sacramento	California	United States	95817
6	San Francisco AIDS Clinic / San Francisco Gen Hosp	San Francisco	California	United States	941102859
7	San Francisco Veterans Administration Med Ctr	San Francisco	California	United States	94121
8	Denver Public Health Dept	Denver	Colorado	United States	80204
9	Miami Veterans Administration Med Ctr	Miami	Florida	United States	33125
10	Univ of South Florida	Tampa	Florida	United States	33612
11	Northwestern Univ Med School	Chicago	Illinois	United States	60611
12	Mem Sloan - Kettering Cancer Ctr	New York	New York	United States	10021
13	SUNY / Health Sciences Ctr at Syracuse	Syracuse	New York	United States	13210
14	Northwest Family Ctr at the Harbor View Med Ctr	Seattle	Washington	United States	98104