Clinical trial NCT00002345: The Safety and Effectiveness of Megace in HIV-Infected Women
Official title: Phase IV Study on the Safety and Efficacy of Megace Oral Suspension in HIV-Positive Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anorexia
Cachexia
HIV Infections
Keywords: Megestrol
Acquired Immunodeficiency Syndrome
Anorexia
Cachexia
Suspensions
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Univ of California - Davis Med Ctr / CARES
state: California
city: New Haven
country: United States
facility: Yale Univ Med School
state: Connecticut
city: Washington
country: United States
facility: Georgetown Univ Med Ctr
state: District of Columbia
city: Providence
country: United States
facility: Miriam Hosp
state: Rhode Island
Study officials:
References: