Clinical trial NCT00002067: A Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia
Official title: Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anorexia
Cachexia
HIV Infections
Keywords: Body Weight
T-Lymphocytes
Nutritional Status
Megestrol
Acquired Immunodeficiency Syndrome
Anorexia
Cachexia
Energy Intake
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 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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dr Mark Goldstein
state: California
city: Oakland
country: United States
facility: Summitt Med Ctr / San Francisco Gen Hosp
state: California
city: Palo Alto
country: United States
facility: Palo Alto Veterans Adm Med Ctr / Stanford Univ
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Med Ctr
state: California
city: Sacramento
country: United States
facility: UCD Med Ctr
state: California
city: San Francisco
country: United States
facility: San Francisco AIDS Clinic / San Francisco Gen Hosp
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Administration Med Ctr
state: California
city: Denver
country: United States
facility: Denver Public Health Dept
state: Colorado
city: Miami
country: United States
facility: Miami Veterans Administration Med Ctr
state: Florida
city: Tampa
country: United States
facility: Univ of South Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern Univ Med School
state: Illinois
city: New York
country: United States
facility: Mem Sloan - Kettering Cancer Ctr
state: New York
city: Syracuse
country: United States
facility: SUNY / Health Sciences Ctr at Syracuse
state: New York
city: Seattle
country: United States
facility: Northwest Family Ctr at the Harbor View Med Ctr
state: Washington
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.