Clinical trial NCT00002300: A Study of Different Doses of Megestrol Acetate in Patients With AIDS Who Have Anorexia and Malnutrition
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anorexia
Cachexia
HIV Infections
Keywords: T-Lymphocytes
Megestrol
Dose-Response Relationship, Drug
Acquired Immunodeficiency Syndrome
Anorexia
Cachexia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Veterans Administration Med Ctr / Univ of Alabama
state: Alabama
city: Long Beach
country: United States
facility: Dr NS Tchekmedyian
state: California
city: Los Angeles
country: United States
facility: Dr Stephen J Gabin Jr
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Med Ctr
state: California
city: Denver
country: United States
facility: Denver Public Health Dept
state: Colorado
city: Washington
country: United States
facility: George Washington Univ Med Ctr
state: District of Columbia
city: Washington
country: United States
facility: Veterans Administration Med Ctr
state: District of Columbia
city: Miami
country: United States
facility: Miami Veterans Administration Med Ctr
state: Florida
city: Chicago
country: United States
facility: Northwestern Univ Med School
state: Illinois
city: Albany
country: United States
facility: Albany Med College / AIDS Treatment Ctr
state: New York
city: New York
country: United States
facility: Community Research Initiative on AIDS
state: New York
city: New York
country: United States
facility: Saint Vincent's Hosp and Med Ctr
state: New York
city: New York
country: United States
facility: Mem Sloan - Kettering Cancer Ctr
state: New York
city: Philadelphia
country: United States
facility: Univ of Pennsylvania
state: Pennsylvania
city: San Antonio
country: United States
facility: Audie L Murphy Veterans Administration Hosp
state: Texas
Study officials:
References:
citation: 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.