Clinical trial NCT00196612: Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART
Official title: Phase II Randomized Trial Comparing Efficacy and Safety of the Maintenance of a HAART Association Protease Inhibitor Containing Versus a Once Daily Antiretroviral Triple Association, in HIV Adult Patients With Undetectable Viral Load.ANRS 099 ALIZE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV Infections
Reverse Transcriptase Inhibitors
Treatment simplification
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
Collaborators: name: Triangle Pharmaceuticals
name: Gilead Sciences
name: Bristol-Myers Squibb
name: Dupont Applied Biosciences
First posted: 2005-09-20
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Virological success from W0 to W48
Secondary outcomes:
measure: Progression of HIV infection
measure: CD4 cell count
measure: Safety
measure: Treatment adherence
measure: Quality of life
measure: Viral mutations
measure: Therapeutic strategy failure
Other outcomes:
Locations:
Study officials:
affiliation: Service de Maladies Infectieuses, Hôpital Saint-Louis, Paris, 75475, France
name: Jean-Michel Molina, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: INSERM unité 593, Bordeaux, France
name: Genevieve Chene, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.