Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196612
• Other study ID #: ANRS 099 ALIZE
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: April 2001
• Est. completion date: September 2004

Study information

• Verified date: September 2005
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• emtricitabine, FTC (drug)

• didanosine, ddI (drug)

• efavirenz (drug)

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis	Bristol-Myers Squibb, Dupont Applied Biosciences, Gilead Sciences, Triangle Pharmaceuticals

References & Publications (1)

Molina JM, Journot V, Morand-Joubert L, Yéni 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. Simplificat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virological success from W0 to W48
Secondary	Progression of HIV infection
Secondary	CD4 cell count
Secondary	Safety
Secondary	Treatment adherence
Secondary	Quality of life
Secondary	Viral mutations
Secondary	Therapeutic strategy failure