NCT00002345

CompletedPhase 4

The Safety and Effectiveness of Megace in HIV-Infected Women

Bristol-Myers Squibb Source

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Other study identifiers

Sponsor study identifier

025C

Secondary identifiers

MEG169-93.007

Study Type

interventional

Reported enrollment (type unavailable)

40

Locations

1 country

Sites

4

Timeline

Study Start

Not reported

Date not reported

Primary Completion

Not reported

Date not reported

Study Completion

Not reported

Date not reported

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 40 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 4 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 2, 1999
Actual (reported)
First Posted
August 31, 2001
Actual (reported)

Last Updated: October 2, 2007
Status Verified: October 2007
Last Update Submitted: October 1, 2007

Conditions

Anorexia Cachexia HIV Infections

Keywords

MegestrolAcquired Immunodeficiency SyndromeAnorexiaCachexiaSuspensions

Interventions

Megestrol acetateDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient must have:
HIV infection.

Sponsors & Collaborators

Bristol-Myers Squibb
Industrylead

Study Sites (4)

Univ of California - Davis Med Ctr / CARES

Sacramento, California, 95817, United States

Yale Univ Med School

New Haven, Connecticut, 065102483, United States

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, 200072197, United States

Miriam Hosp

Providence, Rhode Island, 02906, United States

MeSH Terms

Conditions

AnorexiaCachexiaHIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Megestrol Acetate

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesBody WeightThinnessBlood-Borne InfectionsCommunicable Diseases

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Purpose: TREATMENT
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

October 2, 2007

Record last verified: 2007-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00002345
Data provider: ClinicalTrials.gov
Source updated: 2007-10-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:48 UTC

Locations

NCT00163072

Pharmacokinetics and Safety of Transdermal Megestrol Acetate

Phase 4Withdrawn

NCT00031707

Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite

Phase 3Completed

NCT00000737

A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome

Phase 1Completed

NCT00031785

Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer

Phase 3Completed

NCT00483327

Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate

Phase 2Completed

NCT03815019

iKanEat: A Randomized-controlled, Multi-center Trial of Megestrol for Chronic Oral Food Refusal in Children

Phase 4Completed

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.

You may not qualify if:

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.
+6 more criteria

Contact the study team to confirm eligibility.

Infections

Sexually Transmitted Diseases, Viral

Sexually Transmitted Diseases

Lentivirus Infections

Retroviridae Infections

RNA Virus Infections

Virus Diseases

Genital Diseases

Urogenital Diseases

Immunologic Deficiency Syndromes

Immune System Diseases

Slow Virus Diseases

Intervention Hierarchy (Ancestors)

MegestrolPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

US

(4)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Source record

Locations

You may not qualify if:

Intervention Hierarchy (Ancestors)