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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00122538
• Other study ID #: ANRS 12103 BURKINAME
• Status: Completed
• Phase: Phase 2
• First received: July 19, 2005
• Last updated: December 2, 2011
• Start date: February 2006
• Est. completion date: May 2009

Study information

• Verified date: December 2011
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Burkina Faso: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Months to 15 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• HIV-2 or dual HIV infection

• Previous antiretroviral therapy

• Children unable to swallow pills

• Known resistance to non-nucleoside reverse transcriptase inhibitor (NNRTI)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS
• HIV Infections

Intervention

Drug:
• Efavirenz (EFV)

• Lamivudine (3TC)

• Didanosine (ddI)

Locations

Country	Name	City	State
Burkina Faso	Service de pediatrie, CHU Sanou Souro	Bobo-Dioulasso

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with HIV RNA less than 400 copies per ml and less than 50 copies per ml at month 12 (M12)		12 and 24 months	No
Primary	Cmin and Cmax for the three drugs		15 days	No
Primary	Grade 3 or 4 undesirable effects frequency		through out the trial	Yes
Secondary	Percentage of patients with CD4 greater than 25 percent at M12 and M24		12 and 24 months	No
Secondary	Amplitude of viral load reduction		12 and 24 months	No
Secondary	Slope of CD4 compared with the initial values		12 and 24 months	No
Secondary	Percentage of patients lost to follow-up		12 and 24 months	No
Secondary	Percentage of deaths and of B or C classing events		Through out the trial	Yes
Secondary	Percentage of treatment interruption		Through out the trial	No
Secondary	Percentage and type of resistance mutations		12 and 24 months	No
Secondary	Percentage of patients forgetting more than one pill within the last three days		Through out the trial	No