Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Safety and Effectiveness of Megace in HIV-Infected Women

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002345
First received: November 2, 1999
Last updated: October 1, 2007
Last verified: October 2007
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: Phase IV Study on the Safety and Efficacy of Megace Oral Suspension in HIV-Positive Females

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment: 40
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002345

Locations
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
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002345     History of Changes
Other Study ID Numbers: 025C, MEG169-93.007
Study First Received: November 2, 1999
Last Updated: October 1, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Megestrol
Acquired Immunodeficiency Syndrome
Anorexia
Cachexia
Suspensions

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Anorexia
Cachexia
HIV Infections
Body Weight
Body Weight Changes
Emaciation
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Signs and Symptoms
Signs and Symptoms, Digestive
Slow Virus Diseases
Virus Diseases
Weight Loss
Megestrol
Megestrol Acetate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Appetite Stimulants
Central Nervous System Agents
Central Nervous System Stimulants
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on November 19, 2014