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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00002345 |
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.
Condition | Intervention | Phase |
---|---|---|
Anorexia Cachexia HIV Infections |
Drug: Megestrol acetate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Safety Study |
Official Title: | Phase IV Study on the Safety and Efficacy of Megace Oral Suspension in HIV-Positive Females |
Estimated Enrollment: | 40 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patient must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
United States, California | |
Univ of California - Davis Med Ctr / CARES | |
Sacramento, California, United States, 95817 | |
United States, Connecticut | |
Yale Univ Med School | |
New Haven, Connecticut, United States, 065102483 | |
United States, District of Columbia | |
Georgetown Univ Med Ctr | |
Washington, District of Columbia, United States, 200072197 | |
United States, Rhode Island | |
Miriam Hosp | |
Providence, Rhode Island, United States, 02906 |
Study ID Numbers: | 025C, MEG169-93.007 |
Study First Received: | November 2, 1999 |
Last Updated: | October 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00002345 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Megestrol Acquired Immunodeficiency Syndrome Anorexia Cachexia Suspensions |
Sexually Transmitted Diseases, Viral Antineoplastic Agents, Hormonal Signs and Symptoms, Digestive Contraceptive Agents Contraceptives, Oral Acquired Immunodeficiency Syndrome Contraceptive Agents, Female Cachexia Central Nervous System Stimulants Emaciation Megestrol Immunologic Deficiency Syndromes |
Body Weight Virus Diseases Signs and Symptoms HIV Seropositivity HIV Infections Weight Loss Sexually Transmitted Diseases Body Weight Changes Anorexia Retroviridae Infections Appetite Stimulants Megestrol Acetate |
Sexually Transmitted Diseases, Viral Slow Virus Diseases Signs and Symptoms, Digestive Contraceptive Agents Antineoplastic Agents Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Cachexia Reproductive Control Agents Infection Body Weight Signs and Symptoms Therapeutic Uses Weight Loss |
Body Weight Changes Contraceptives, Oral, Synthetic Retroviridae Infections Appetite Stimulants RNA Virus Infections Immune System Diseases Antineoplastic Agents, Hormonal Acquired Immunodeficiency Syndrome Central Nervous System Stimulants Emaciation Megestrol Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases HIV Infections |