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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002067
Other study ID # 025B
Secondary ID MEG8809
Status Completed
Phase Phase 3
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 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
Est. completion date
Est. primary completion date
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.

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.

Study Design

Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Megestrol acetate


Locations

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

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

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