The Safety and Effectiveness of Megace in HIV-Infected Women

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00002345

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Cachexia HIV Infections	Drug: Megestrol acetate	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

Phase IV Study on the Safety and Efficacy of Megace Oral Suspension in HIV-Positive Females

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of California - Davis Med Ctr / CARES	Sacramento	California	United States	95817
2	Yale Univ Med School	New Haven	Connecticut	United States	065102483
3	Georgetown Univ Med Ctr	Washington	District of Columbia	United States	200072197
4	Miriam Hosp	Providence	Rhode Island	United States	02906