HIV InfectionsNCT00002182
A Study of Megestrol Acetate in HIV-Infected Children
A study testing Megestrol acetate in people with HIV Infections, run by Gamma Project - ACTU at 1 site in Puerto Rico.
Trial summary
The purpose of this study is to see if megestrol acetate is safe and effective in treating HIV-infected children with failure to thrive (FTT). Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Megestrol acetate
- How many people
- 25 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must have:
- Documented HIV infection.
- Failure to thrive as defined by:
- crossing 2 percentile lines on standard weight for age curves over time or less than 5% percentile weight for age and falling from the curve or loss of 10% of baseline body weight.
- Resistant to oral nutritional supplementation (i.e., FTT despite a minimum 1-month trial of high-calorie oral supplements).
- Free of significant acute illness (mild upper respiratory tract infections allowed).
- Patients with chronic diarrhea allowed provided malabsorption and gastrointestinal infection ruled out.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms are excluded:
- Gastrointestinal infection or malabsorption.
- Significant acute illness.
- Any identified, untreated cause for failure to thrive other than underlying HIV infection.
- Medical contraindications to megestrol acetate.
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- Patients with any of the following prior conditions or symptoms are excluded:
- Medical contraindications to megestrol acetate including a history of poorly-controlled hypertension, deep venous thrombosis, or heart failure.
- History of prior megestrol acetate therapy in the past six months.
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
Univ of Puerto Rico / Med Science Campus
San Juan, 00936
About this study
Official title: Megestrol Acetate For Failure To Thrive In Pediatric HIV
The purpose of this study is to see if megestrol acetate is safe and effective in treating HIV-infected children with failure to thrive (FTT).
Read the detailed description
The study design is randomized, double-blind, placebo-controlled for 12 weeks with open-label drug offered after week 12.
- Conditions
- HIV Infections
- Being tested
- Megestrol acetate
- Keywords
- Placebos, Appetite Stimulants, Megestrol Acetate, Failure to Thrive
- Medical subject headings
- HIV Infections, Failure to Thrive
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 HIV InfectionsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Gamma Project - ACTU
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002182
- Sponsor's protocol ID
- 266A
- Other IDs
- Gamma 005
- Status last verified
- Jul 1998
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Megestrol Acetate For Failure To Thrive In Pediatric HIV
- ClinicalTrials.gov ID
- NCT00002182
- Acronym / sponsor ID
- 266A
- Conditions
- HIV Infections
- Keywords
- Placebos, Appetite Stimulants, Megestrol Acetate, Failure to Thrive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- Gamma Project - ACTUUniversity, hospital or other
- 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.
The purpose of this study is to see if megestrol acetate is safe and effective in treating HIV-infected children with failure to thrive (FTT).
Detailed description
The study design is randomized, double-blind, placebo-controlled for 12 weeks with open-label drug offered after week 12.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Documented HIV infection.
- Failure to thrive as defined by:
- crossing 2 percentile lines on standard weight for age curves over time or less than 5% percentile weight for age and falling from the curve or loss of 10% of baseline body weight.
- Resistant to oral nutritional supplementation (i.e., FTT despite a minimum 1-month trial of high-calorie oral supplements).
- Free of significant acute illness (mild upper respiratory tract infections allowed).
Key exclusion criteria (9 listed)
- Gastrointestinal infection or malabsorption.
- Significant acute illness.
- Any identified, untreated cause for failure to thrive other than underlying HIV infection.
- Medical contraindications to megestrol acetate.
- Medical contraindications to megestrol acetate including a history of poorly-controlled hypertension, deep venous thrombosis, or heart failure.
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 24 Jun 2005.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Megestrol acetate in people with HIV Infections, run by Gamma Project - ACTU at 1 site in Puerto Rico.
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 7 inclusion and 9 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. 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.
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 24 Jun 2005.