Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART

NCT ID: NCT00196612

Last Updated: 2005-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2004-09-30

Brief Summary

The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults. In those with an undetectable viral load, a once daily combination of FTC, ddI, efavirenz would be easier to take, with less side effects and the same efficacy. The aim of the study was to evaluate if the once daily combination presents the same efficacy than the HAART therapy with less side effects and a better adherence.

Detailed Description

The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults, but side effects an the great number of pills induces less adherence to the therapy. Once daily combination with a lower number of pills could be more easy to take, with a greater adherence, less side effects, and the same efficacy. 355 patients are recruited in the study, randomized in two treatment groups: maintenance of the HAART therapy versus changing for a once daily combination of FTC, ddI, efavirenz, during 48 weeks. The primary end-point is the viral success maintained until 48 weeks. Secondary end-point is the safety and adherence.

The trial is prolonged for a total of 48 weeks.

Conditions

HIV Infections

Keywords

HIV Infections; Reverse Transcriptase Inhibitors; Treatment simplification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

emtricitabine, FTC (drug)

Intervention Type: DRUG

didanosine, ddI (drug)

Intervention Type: DRUG

efavirenz (drug)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• HIV infected adults
• Antiretroviral treatment since 6 months, with two nucleoside analogues and one or two protease inhibitors
• CD4 cell count over 100/mm3
• HIV RNA below 400 copies/ml since 6 months
• Signed written informed consent

Exclusion Criteria

• Previous treatment with non nucleoside analogue, ddI alone
• Pregnancy
• Alcool abuse
• Acute infection, past neurological or pancreatic disease, biological abnormalities
• Chemotherapy or immunotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Triangle Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Dupont Applied Biosciences

INDUSTRY

Sponsor Role: collaborator

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Jean-Michel Molina, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Service de Maladies Infectieuses, Hôpital Saint-Louis, Paris, 75475, France

Genevieve Chene, MD, PhD

Role: STUDY_DIRECTOR

INSERM unité 593, Bordeaux, France

References

Molina JM, Journot V, Morand-Joubert L, Yeni P, Rozenbaum W, Rancinan C, Fournier S, Morlat P, Palmer P, Dupont B, Goujard C, Dellamonica P, Collin F, Poizot-Martin I, Chene G; ALIZE (Agence Nationale de Recherches sur le SIDA 099) Study Team. Simplification therapy with once-daily emtricitabine, didanosine, and efavirenz in HIV-1-infected adults with viral suppression receiving a protease inhibitor-based regimen: a randomized trial. J Infect Dis. 2005 Mar 15;191(6):830-9. doi: 10.1086/428091. Epub 2005 Feb 10.

Reference Type: RESULT

PMID: 15717256 (View on PubMed)

Other Identifiers

ANRS 099 ALIZE

Identifier Type: -

Identifier Source: org_study_id