- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002345
The Safety and Effectiveness of Megace in HIV-Infected Women
October 1, 2007 updated by: Bristol-Myers Squibb
Phase IV Study on the Safety and Efficacy of Megace Oral Suspension in HIV-Positive Females
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.
Study Overview
Status
Completed
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Sacramento, California, United States, 95817
- Univ of California - Davis Med Ctr / CARES
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Connecticut
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New Haven, Connecticut, United States, 065102483
- Yale Univ Med School
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District of Columbia
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Washington, District of Columbia, United States, 200072197
- Georgetown Univ Med Ctr
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Miriam Hosp
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (ESTIMATE)
August 31, 2001
Study Record Updates
Last Update Posted (ESTIMATE)
October 2, 2007
Last Update Submitted That Met QC Criteria
October 1, 2007
Last Verified
October 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Signs and Symptoms, Digestive
- Nutrition Disorders
- Body Weight
- Body Weight Changes
- Emaciation
- Weight Loss
- Anorexia
- Wasting Syndrome
- Cachexia
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Central Nervous System Stimulants
- Appetite Stimulants
- Megestrol
- Megestrol Acetate
Other Study ID Numbers
- 025C
- MEG169-93.007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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