- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002300
A Study of Different Doses of Megestrol Acetate in Patients With AIDS Who Have Anorexia and Malnutrition
October 1, 2007 updated by: Bristol-Myers Squibb
Phase II-III Randomized Double-Blind Study Comparing Megestrol Acetate at 100, 400, and 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia
To compare the effects of megestrol acetate and placebo on body weight, anorexia, cachexia, calorie intake, and nutritional parameters of patients with a confirmed diagnosis of AIDS.
To characterize dose response in relation to weight gain.
To determine whether megestrol acetate relative to placebo improves the perception of well-being among AIDS patients with cachexia.
To evaluate megestrol acetate's effect on immune function via skin test reactivity, T4/T8 ratio, and total lymphocytes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
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
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- Birmingham Veterans Administration Med Ctr / Univ of Alabama
-
-
California
-
Long Beach, California, United States, 90801
- Dr NS Tchekmedyian
-
Los Angeles, California, United States, 90067
- Dr Stephen J Gabin Jr
-
Rancho Mirage, California, United States, 92270
- Eisenhower Med Ctr
-
-
Colorado
-
Denver, Colorado, United States, 80204
- Denver Public Health Dept
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20037
- George Washington Univ Med Ctr
-
Washington, District of Columbia, United States, 20422
- Veterans Administration Med Ctr
-
-
Florida
-
Miami, Florida, United States, 33125
- Miami Veterans Administration Med Ctr
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern Univ Med School
-
-
New York
-
Albany, New York, United States, 12203
- Albany Med College / AIDS Treatment Ctr
-
New York, New York, United States, 10021
- Mem Sloan - Kettering Cancer Ctr
-
New York, New York, United States, 10011
- Saint Vincent's Hosp and Med Ctr
-
New York, New York, United States, 10010
- Community Research Initiative on AIDS
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Univ of Pennsylvania
-
-
Texas
-
San Antonio, Texas, United States, 78284
- Audie L Murphy Veterans Administration Hosp
-
-
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
All
Description
Inclusion Criteria
Patient must have:
- Confirmed diagnosis of AIDS (CDC definition).
- Documented weight loss or anorexia.
- Life expectancy = or > 20 weeks.
- The perception that the weight loss is a detriment to their well-being.
- Ability to provide informed consent, read and write English.
Prior Medication:
Allowed:
- Ganciclovir.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Dementia or evidence of mental incompetence which would preclude compliance with the protocol.
- Diarrhea defined as 5 or more watery stools per day for at least 7 days.
- Active uncontrolled systemic infections at the start of treatment.
- (Patients may not be entered for at least 2 weeks after acute infection.) Clinical or radiologic evidence of ascites or pleural effusions.
Concurrent Medication:
Excluded:
- Therapy designed to treat the underlying HIV infection or which may have a major impact on appetite and/or weight gain.
- Patients who have been started on zidovudine (AZT) within eight weeks. (Patients may have been previously treated with AZT and failed or may currently be receiving AZT for at least 8 weeks.)
Patients with the following are excluded:
- Obstruction to food intake or impaired digestive/absorptive functions.
- Contraindications to high-dose megestrol acetate (poorly controlled hypertension or heart failure or deep vein thrombosis).
- Inability to consent or be available for close follow-up.
- Active systemic infections at the start of treatment.
- Patients may not be started on any therapy designed to treat the underlying HIV infection or which may have a major impact on appetite and/or weight gain.
- Clinical or radiologic evidence of ascites or pleural effusions.
- Patients may not be started on any therapy designed to treat the underlying HIV infection or which may have a major impact on appetite and/or weight gain.
- Patients who have been hospitalized or have suffered an exacerbation of their illness associated with weight loss within the past 2 weeks are excluded.
- Menstruating female patients are excluded.
Prior Medication:
Excluded:
- Corticosteroids.
- Anabolic steroids.
- Marijuana.
- Megestrol acetate.
- Patients who have been started on zidovudine (AZT) within 8 weeks. (Patients may have been previously treated with AZT and failed or may currently be receiving AZT for at least 8 weeks.) History of substance abuse and questionable current and future abstinence.
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
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
Keywords
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
- 025A
- MEG8807
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.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Megestrol acetate
-
Southwest Oncology GroupNational Cancer Institute (NCI)CompletedBreast Cancer | Hot Flashes
-
Xiaojun ChenZhejiang Cancer Hospital; Fudan University; Shanghai 6th People's Hospital; Shanghai...CompletedEndometrial Adenocarcinoma | Endometrial Atypical HyperplasiaChina
-
Par Pharmaceutical, Inc.PRA Health SciencesTerminatedAnorexia | Weight Loss | CachexiaUnited States
-
Bristol-Myers SquibbCompletedHIV Infections | Anorexia | CachexiaUnited States
-
Endo PharmaceuticalsQuintiles, Inc.CompletedHIV Infections | Anorexia | Cachexia | HIV Wasting Syndrome | AIDS Wasting SyndromeUnited States, India, South Africa
-
Bristol-Myers SquibbCompletedHIV Infections | Anorexia | CachexiaUnited States
-
St. Vincent Medical Center - Los AngelesUnknownBreast Cancer | Malignant Mesothelioma | Endometrial CancerUnited States
-
Northwestern UniversityNational Cancer Institute (NCI)CompletedFatigue | Unspecified Adult Solid Tumor, Protocol Specific | CachexiaUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedAnorexia | Lung Cancer | CachexiaUnited States
-
National Medical Research Council (NMRC), SingaporeCompletedLiver CancerSingapore, Bangladesh, Thailand, Vietnam, Philippines, Indonesia, Korea, Republic of, Myanmar, New Zealand, Taiwan