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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00002300

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 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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Cachexia HIV Infections	Drug: Megestrol acetate	Phase 2

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

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

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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham Veterans Administration Med Ctr / Univ of Alabama	Birmingham	Alabama	United States	35233
2	Dr NS Tchekmedyian	Long Beach	California	United States	90801
3	Dr Stephen J Gabin Jr	Los Angeles	California	United States	90067
4	Eisenhower Med Ctr	Rancho Mirage	California	United States	92270
5	Denver Public Health Dept	Denver	Colorado	United States	80204
6	George Washington Univ Med Ctr	Washington	District of Columbia	United States	20037
7	Veterans Administration Med Ctr	Washington	District of Columbia	United States	20422
8	Miami Veterans Administration Med Ctr	Miami	Florida	United States	33125
9	Northwestern Univ Med School	Chicago	Illinois	United States	60611
10	Albany Med College / AIDS Treatment Ctr	Albany	New York	United States	12203
11	Community Research Initiative on AIDS	New York	New York	United States	10010
12	Saint Vincent's Hosp and Med Ctr	New York	New York	United States	10011
13	Mem Sloan - Kettering Cancer Ctr	New York	New York	United States	10021
14	Univ of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
15	Audie L Murphy Veterans Administration Hosp	San Antonio	Texas	United States	78284