HIV InfectionsPhase 2NCT00122538

Once-daily Highly Active Antiretroviral Treatment Regimen Administration in HIV-1 Infected Children in Burkina Faso (ANRS 12103 BURKINAME)

A Phase 2 study testing Efavirenz (EFV), Lamivudine (3TC) and Didanosine (ddI) in people with HIV Infections and AIDS, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in Burkina Faso.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 months to 15 years
Conditions the study is for: HIV Infections, AIDS
What is being tested?: Efavirenz (EFV), Lamivudine (3TC) and Didanosine (ddI)
How many people: 52 participants
Where: 1 siteBurkina Faso
Study dates: Feb 2006to May 2009
Phase: Phase 2
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 30 months to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

HIV-1 infected children
Weight over 12 kgs
Age over 30 months
Clinical stage requiring HAART
Naive to antiretroviral treatment (except PMTCT prophylaxis)
Mother's or tutor's informed consent signed

Who cannot join

HIV-2 or dual HIV infection
Previous antiretroviral therapy
Children unable to swallow pills
Known resistance to non-nucleoside reverse transcriptase inhibitor (NNRTI)

Trial locations and contacts

1 site in 1 country.

Burkina Faso1 site

Service de pediatrie, CHU Sanou Souro
Bobo-Dioulasso, 01 BP 676

Other trials in Burkina Faso

About this study

Official title: HAART Regimen Comprising 3TC + ddI + EFV in Once-daily Administration in HIV-1 Infected Children in Burkina Faso

The purpose of this study is to try a known antiretroviral combination in HIV- infected children with only one intake a day, in order to simplify the prescription and improve adherence to treatment. This is what is called a phase II clinical trial, only recruiting and following a small number of children (50) during one year to evaluate the quantity of drug in the blood just before it is taken and one to three hours after it is taken. The other important objective is to study the tolerance of drugs in that mode of prescription of the triple combination.

Read the detailed description

The data relating to pharmacology tolerance and efficacy of the once-daily combination of 3TC + ddI + EFV have never been studied.

This regimen may lead to a better treatment of the HIV-1 infected children in developing countries, as well as in Europe. Because of its simplicity it would facilitate observance that is one of the essential parameters of efficacy of treatments.

The main objectives are those of a phase II clinical trial:

Assess the virological and immunological efficacy of a once daily HAART regimen comprising lamivudine (3TC) + didanosine (ddI) + efavirenz (EFV) [pediatric reference];
Analyse the pharmacological characteristics of this combination in children;
Assess the tolerance;
Study the appearance of resistance;
Evaluate the observance to treatment. 50 HIV-1 infected children aged 30 months to 15 years whose clinical and immunological state (stage B or C) requires antiretroviral treatment, will be included in the study. They should be naive of any ARV treatment (except the treatment received in the framework of PMTCT (Prevention of Mother to Child Transmission).

Data Collection and Development of the Study:

Monthly clinical examination;
RNA HIV-1 and CD4 counts;
Pharmacological dosages;
Haematology and biochemistry surveillance;
Genotypic resistance at inclusion; and, in case of unsuccess or failure,
Assessment of observance according to alternate methods.

Laboratory examinations will be carried out at Centre Muraz except for genotyping and for pharmacological tests sent to Montpellier Teaching Hospital (France).

Conditions: HIV Infections, AIDS
Being tested: Efavirenz (EFV), Lamivudine (3TC), Didanosine (ddI)
Keywords: HAART, once-daily, child, africa, HIV, AIDS, Treatment Naive
Medical subject headings: HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Efavirenz (EFV)Drug
Lamivudine (3TC)Drug
Didanosine (ddI)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of patients with HIV RNA less than 400 copies per ml and less than 50 copies per ml at month 12 (M12)
Measured: 12 and 24 months
Cmin and Cmax for the three drugs
Measured: 15 days
Grade 3 or 4 undesirable effects frequency
Measured: through out the trial

Secondary outcomes (8)

Percentage of patients with CD4 greater than 25 percent at M12 and M24
Measured: 12 and 24 months
Amplitude of viral load reduction
Measured: 12 and 24 months
Slope of CD4 compared with the initial values
Measured: 12 and 24 months
Percentage of patients lost to follow-up
Measured: 12 and 24 months
Percentage of deaths and of B or C classing events
Measured: Through out the trial
Percentage of treatment interruption
Measured: Through out the trial
Percentage and type of resistance mutations
Measured: 12 and 24 months
Percentage of patients forgetting more than one pill within the last three days
Measured: Through out the trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2006May 2009

First posted22 Jul 2005 (estimated)
Study startFeb 2006
Primary completionNov 2008
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00122538
Sponsor's protocol ID: ANRS 12103 BURKINAME
Status last verified: Dec 2011
First submitted: 19 Jul 2005
Last updated: 5 Dec 2011
Results posted: No
Data monitoring committee: Yes

Publications

Bouazza N, Treluyer JM, Msellati P, Van de Perre P, Diagbouga S, Nacro B, Hien H, Zoure E, Rouet F, Ouiminga A, Blanche S, Hirt D, Urien S. A novel pharmacokinetic approach to predict virologic failure in HIV-1-infected paediatric patients. AIDS. 2013 Mar 13;27(5):761-8. doi: 10.1097/QAD.0b013e32835caad1.
PubMed 23719348
Barro M, Some J, Foulongne V, Diasso Y, Zoure E, Hien H, Francois R, Michel S, Drabo A, Tamboura H, Ouiminga A, Diagbouga S, Hien A, Yameogo S, Van De Perre P, Nacro B, Msellati P. Short-term virological efficacy, immune reconstitution, tolerance, and adherence of once-daily dosing of didanosine, lamivudine, and efavirenz in HIV-1-infected African children: ANRS 12103 Burkiname. J Acquir Immune Defic Syndr. 2011 Jul 1;57 Suppl 1:S44-9. doi: 10.1097/QAI.0b013e31821fd64f.
PubMed 21857286
Bouazza N, Hirt D, Bardin C, Diagbouga S, Nacro B, Hien H, Zoure E, Rouet F, Ouiminga A, Blanche S, Van De Perre P, Treluyer JM, Msellati P, Urien S. Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children? Antimicrob Agents Chemother. 2010 Aug;54(8):3280-6. doi: 10.1128/AAC.00306-10. Epub 2010 Jun 1.
PubMed 20516271

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: HAART Regimen Comprising 3TC + ddI + EFV in Once-daily Administration in HIV-1 Infected Children in Burkina Faso
ClinicalTrials.gov ID: NCT00122538
Acronym / sponsor ID: ANRS 12103 BURKINAME
Conditions: HIV Infections, AIDS
Keywords: HAART, once-daily, child, africa, HIV, AIDS, Treatment Naive
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: French National Agency for Research on AIDS and Viral HepatitisOther government
Study start: Feb 2006
Primary completion: Nov 2008 (actual)
Study completion: May 2009 (actual)
First posted: 22 Jul 2005 (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.

Detailed description

The data relating to pharmacology tolerance and efficacy of the once-daily combination of 3TC + ddI + EFV have never been studied.

The main objectives are those of a phase II clinical trial:

Assess the virological and immunological efficacy of a once daily HAART regimen comprising lamivudine (3TC) + didanosine (ddI) + efavirenz (EFV) [pediatric reference];
Analyse the pharmacological characteristics of this combination in children;
Assess the tolerance;
Study the appearance of resistance;
Evaluate the observance to treatment. 50 HIV-1 infected children aged 30 months to 15 years whose clinical and immunological state (stage B or C) requires antiretroviral treatment, will be included in the study. They should be naive of any ARV treatment (except the treatment received in the framework of PMTCT (Prevention of Mother to Child Transmission).

Data Collection and Development of the Study:

Monthly clinical examination;
RNA HIV-1 and CD4 counts;
Pharmacological dosages;
Haematology and biochemistry surveillance;
Genotypic resistance at inclusion; and, in case of unsuccess or failure,
Assessment of observance according to alternate methods.

Laboratory examinations will be carried out at Centre Muraz except for genotyping and for pharmacological tests sent to Montpellier Teaching Hospital (France).

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 30 months to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

HIV-1 infected children
Weight over 12 kgs
Age over 30 months
Clinical stage requiring HAART
Naive to antiretroviral treatment (except PMTCT prophylaxis)

Key exclusion criteria (4 listed)

HIV-2 or dual HIV infection
Previous antiretroviral therapy
Children unable to swallow pills
Known resistance to non-nucleoside reverse transcriptase inhibitor (NNRTI)

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
Efavirenz (EFV)	Drug	–
Lamivudine (3TC)	Drug	–
Didanosine (ddI)	Drug	–

Primary outcome

Percentage of patients with HIV RNA less than 400 copies per ml and less than 50 copies per ml at month 12 (M12)
Time frame: 12 and 24 months
Cmin and Cmax for the three drugs
Time frame: 15 days
Grade 3 or 4 undesirable effects frequency
Time frame: through out the trial

8 secondary outcomes

Percentage of patients with CD4 greater than 25 percent at M12 and M24
Time frame: 12 and 24 months
Amplitude of viral load reduction
Time frame: 12 and 24 months
Slope of CD4 compared with the initial values
Time frame: 12 and 24 months
Percentage of patients lost to follow-up
Time frame: 12 and 24 months
Percentage of deaths and of B or C classing events
Time frame: Through out the trial
Percentage of treatment interruption
Time frame: Through out the trial
Percentage and type of resistance mutations
Time frame: 12 and 24 months
Percentage of patients forgetting more than one pill within the last three days
Time frame: Through out the trial

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 5 Dec 2011.
Derived from this study: PubMed 23719348Bouazza N, Treluyer JM, Msellati P, Van de Perre P, Diagbouga S, Nacro B, Hien H, Zoure E, Rouet F, Ouiminga A, Blanche S, Hirt D, Urien S. A novel pharmacokinetic approach to predict virologic failure in HIV-1-infected paediatric patients. AIDS. 2013 Mar 13;27(5):761-8. doi: 10.1097/QAD.0b013e32835caad1.
Derived from this study: PubMed 21857286Barro M, Some J, Foulongne V, Diasso Y, Zoure E, Hien H, Francois R, Michel S, Drabo A, Tamboura H, Ouiminga A, Diagbouga S, Hien A, Yameogo S, Van De Perre P, Nacro B, Msellati P. Short-term virological efficacy, immune reconstitution, tolerance, and adherence of once-daily dosing of didanosine, lamivudine, and efavirenz in HIV-1-infected African children: ANRS 12103 Burkiname. J Acquir Immune Defic Syndr. 2011 Jul 1;57 Suppl 1:S44-9. doi: 10.1097/QAI.0b013e31821fd64f.
Derived from this study: PubMed 20516271Bouazza N, Hirt D, Bardin C, Diagbouga S, Nacro B, Hien H, Zoure E, Rouet F, Ouiminga A, Blanche S, Van De Perre P, Treluyer JM, Msellati P, Urien S. Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children? Antimicrob Agents Chemother. 2010 Aug;54(8):3280-6. doi: 10.1128/AAC.00306-10. Epub 2010 Jun 1.

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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.

Philippe Msellati, MD, PhD study chair

Institut de Recherche et de Développement (IRD UMR 145)

Aboubacar Nacro, MD principal investigator

CHU Sanou Souro, Bobo-Dioulasso

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 5 Dec 2011. 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 Burkina Faso. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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.

What does the primary outcome measure?

Percentage of patients with HIV RNA less than 400 copies per ml and less than 50 copies per ml at month 12 (M12) (time frame: 12 and 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00122538, which also lists 3 linked publications.

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 5 Dec 2011.