The Safety and Effectiveness of Megace in HIV-Infected Women

Overview

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.

Full Title of Study: “Phase IV Study on the Safety and Efficacy of Megace Oral Suspension in HIV-Positive Females”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Primary Purpose: Treatment

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.

Interventions

  • Drug: Megestrol acetate

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb

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