AnorexiaPhase 3NCT00002067
A Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia
A Phase 3 study testing Megestrol acetate in people with Anorexia and Cachexia, run by Bristol-Myers Squibb at 14 sites in United States.
Trial summary
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 determine whether megestrol acetate relative to placebo improves the perception of well-being among AIDS patients with cachexia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anorexia, Cachexia, HIV Infections
- What is being tested?
- Megestrol acetate
- How many people
- Not given
- Where
- 14 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions are excluded:
- Dementia or evidence of mental incompetence which would preclude compliance with the protocol.
- Severe 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.
Show all 25Show fewer
- Clinical or radiologic evidence of ascites or pleural effusions.
- Patients with the following are excluded:
- Obstruction to food intake or impaired digestive/absorptive functions.
- Contraindications to 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.
- Clinical or radiologic evidence of ascites or pleural effusions.
- 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.)
- 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 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Northwestern Univ Med School
Chicago, Illinois, 60611
Denver Public Health Dept
Denver, Colorado, 80204
Dr Mark Goldstein
Los Angeles, California, 90048
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, 94304
Eisenhower Med Ctr
Rancho Mirage, California, 92270
UCD Med Ctr
Sacramento, California, 95817
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
Northwest Family Ctr at the Harbor View Med Ctr
Seattle, Washington, 98104
SUNY / Health Sciences Ctr at Syracuse
Syracuse, New York, 13210
Univ of South Florida
Tampa, Florida, 33612
About this study
Official title: Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 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 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.
- Conditions
- Anorexia, Cachexia, HIV Infections
- Being tested
- Megestrol acetate
- Keywords
- Body Weight, T-Lymphocytes, Nutritional Status, Megestrol, Acquired Immunodeficiency Syndrome, Anorexia, Cachexia, Energy Intake
- Medical subject headings
- Anorexia, Cachexia, HIV Infections, Body Weight, 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002067
- Sponsor's protocol ID
- 025B
- Other IDs
- MEG8809
- Status last verified
- Oct 2007
- First submitted
- 2 Nov 1999
- Last updated
- 2 Oct 2007
- Results posted
- No
Publications
Strang P. The effect of megestrol acetate on anorexia, weight loss and cachexia in cancer and AIDS patients (review). Anticancer Res. 1997 Jan-Feb;17(1B):657-62.
PubMed 9066597
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 III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia
- ClinicalTrials.gov ID
- NCT00002067
- Acronym / sponsor ID
- 025B
- Conditions
- Anorexia, Cachexia, HIV Infections
- Keywords
- Body Weight, T-Lymphocytes, Nutritional Status, Megestrol, Acquired Immunodeficiency Syndrome, Anorexia, Cachexia, Energy Intake
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- 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 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 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 design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (25 listed)
- Dementia or evidence of mental incompetence which would preclude compliance with the protocol.
- Severe 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.
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.
- Background: PubMed 9066597Strang P. The effect of megestrol acetate on anorexia, weight loss and cachexia in cancer and AIDS patients (review). Anticancer Res. 1997 Jan-Feb;17(1B):657-62.
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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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Megestrol acetate in people with Anorexia and Cachexia, run by Bristol-Myers Squibb at 14 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 6 inclusion and 25 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 14 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
On the ClinicalTrials.gov record for NCT00002067, which also lists 1 linked publication.
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.