Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART

This study has been completed.
Sponsor:
Collaborators:
Triangle Pharmaceuticals
Gilead Sciences
Bristol-Myers Squibb
Dupont Applied Biosciences
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00196612
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 12, 2005
September 12, 2005
April 2001
Not Provided
Virological success from W0 to W48
Same as current
No Changes Posted
  • Progression of HIV infection
  • CD4 cell count
  • Safety
  • Treatment adherence
  • Quality of life
  • Viral mutations
  • Therapeutic strategy failure
Same as current
Not Provided
Not Provided
 
Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: emtricitabine, FTC (drug)
  • Drug: didanosine, ddI (drug)
  • Drug: efavirenz (drug)
Not Provided
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. Epub 2005 Feb 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
September 2004
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00196612
ANRS 099 ALIZE
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
  • Triangle Pharmaceuticals
  • Gilead Sciences
  • Bristol-Myers Squibb
  • Dupont Applied Biosciences
Principal Investigator: Jean-Michel Molina, MD, PhD Service de Maladies Infectieuses, Hôpital Saint-Louis, Paris, 75475, France
Study Director: Genevieve Chene, MD, PhD INSERM unité 593, Bordeaux, France
French National Agency for Research on AIDS and Viral Hepatitis
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP