The Safety and Effectiveness of Megace in HIV-Infected Women - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	October 1, 2007
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002345 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	The Safety and Effectiveness of Megace in HIV-Infected Women
Official Title ^ICMJE	Phase IV Study on the Safety and Efficacy of Megace Oral Suspension in HIV-Positive Females
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.
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Safety Study
Condition ^ICMJE	Anorexia Cachexia HIV Infections
Intervention ^ICMJE	Drug: Megestrol acetate
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002345
Responsible Party
Study ID Numbers ^ICMJE	025C, MEG169-93.007
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Bristol-Myers Squibb
Verification Date	October 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP