AnorexiaPhase 4NCT00002345
The Safety and Effectiveness of Megace in HIV-Infected Women
A Phase 4 study testing Megestrol acetate in people with Anorexia and Cachexia, run by Bristol-Myers Squibb at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anorexia, Cachexia, HIV Infections
- What is being tested?
- Megestrol acetate
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Poorly controlled hypertension.
- Heart failure.
- Deep vein thrombosis.
- Uncontrolled severe diarrhea.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Yale Univ Med School
New Haven, Connecticut, 065102483
Miriam Hosp
Providence, Rhode Island, 02906
Univ of California - Davis Med Ctr / CARES
Sacramento, California, 95817
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 200072197
About this study
Official title: 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.
Read the 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.
- Conditions
- Anorexia, Cachexia, HIV Infections
- Being tested
- Megestrol acetate
- Keywords
- Megestrol, Acquired Immunodeficiency Syndrome, Anorexia, Cachexia, Suspensions
- Medical subject headings
- Anorexia, Cachexia, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Megestrol acetateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnorexiaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002345
- Sponsor's protocol ID
- 025C
- Other IDs
- MEG169-93.007
- Status last verified
- Oct 2007
- First submitted
- 2 Nov 1999
- Last updated
- 2 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study on the Safety and Efficacy of Megace Oral Suspension in HIV-Positive Females
- ClinicalTrials.gov ID
- NCT00002345
- Acronym / sponsor ID
- 025C
- Conditions
- Anorexia, Cachexia, HIV Infections
- Keywords
- Megestrol, Acquired Immunodeficiency Syndrome, Anorexia, Cachexia, Suspensions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (21 listed)
- Poorly controlled hypertension.
- Heart failure.
- Deep vein thrombosis.
- Uncontrolled severe diarrhea.
- Treatable active current infection (excluding chronic low-grade opportunistic infections).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Megestrol acetate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Megestrol acetate in people with Anorexia and Cachexia, run by Bristol-Myers Squibb at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2007.