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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002345
Other study ID # 025C
Secondary ID MEG169-93.007
Status Completed
Phase Phase 4
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 further evaluate the safety of megestrol acetate (Megace) oral suspension in the treatment of anorexia and cachexia in HIV-positive women. To compare the effectiveness of 2 doses of Megace by measurement of weight gain, appetite grade, and other parameters at 12 and 24 weeks.


Description:

Patients are randomized to receive 1 of 2 doses of Megace oral suspension daily for 24 weeks; at 12 weeks, those receiving the lower dose who have not gained 5 pounds over baseline or had appetite improvement to good or excellent are escalated to the higher dose. Patients are evaluated at 4-week intervals. Dose may be adjusted to maintain a desired weight.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria

Patient must have:

- HIV infection.

- Evidence of HIV wasting syndrome that includes anorexia (appetite fair or poor) and weight loss >= 10 percent of pre-illness body weight.

- Perception of weight loss as a detriment.

- Life expectancy of at least 24 weeks.

Prior Medication:

Allowed:

- Megestrol acetate for weight gain at a dose < 400 mg for < 60 days, provided therapy was discontinued at least 3 months prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Poorly controlled hypertension.

- Heart failure.

- Deep vein thrombosis.

- Uncontrolled severe diarrhea.

- Treatable active current infection (excluding chronic low-grade opportunistic infections).

- Unable to intake food.

- Impaired digestive/absorptive function.

Concurrent Medication:

Excluded:

- Initiation during the study of any therapy to treat HIV or anorexia/cachexia (other than study drug).

Patients with the following prior conditions are excluded:

- Hospitalization for or exacerbation of illness associated with weight loss within the past 2 weeks.

- Participation in other investigational drug studies within the past month.

- Previous abnormal mammogram (if 35-40 years of age) or abnormal mammogram within the past year (if over 40 years of age).

Prior Medication:

Excluded:

- New antiviral therapy within the past 8 weeks.

- Medications to promote weight gain (e.g., corticosteroid, dronabinol) within the past 2 months.

- Megestrol acetate within the past 3 months. IV drug abuse not treated for at least 4 months.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Megestrol acetate


Locations

Country Name City State
United States Yale Univ Med School New Haven Connecticut
United States Miriam Hosp Providence Rhode Island
United States Univ of California - Davis Med Ctr / CARES Sacramento California
United States Georgetown Univ Med Ctr Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

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