The Safety and Effectiveness of Megace in HIV-Infected Women
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anorexia; Cachexia; HIV Infections
Intervention: Megestrol acetate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bristol-Myers Squibb
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.
Clinical Details
Official title: Phase IV Study on the Safety and Efficacy of Megace Oral Suspension in HIV-Positive Females
Study design: Treatment, Randomized, Safety Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Univ of California - Davis Med Ctr / CARES, Sacramento, California 95817, United States
Yale Univ Med School, New Haven, Connecticut 065102483, United States
Georgetown Univ Med Ctr, Washington, District of Columbia 200072197, United States
Miriam Hosp, Providence, Rhode Island 02906, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Last updated: October 1, 2007
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