NCT00196612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P25-P50 for phase_3 hiv-infections

Timeline
Completed

Started Apr 2001

Typical duration for phase_3 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

June 15, 2026

Status Verified

June 1, 2026

First QC Date

September 12, 2005

Last Update Submit

June 12, 2026

Conditions

HIV Infections

Keywords

HIV InfectionsReverse Transcriptase InhibitorsTreatment simplification

Outcome Measures

Primary Outcomes (1)

  • Virological success from W0 to W48

Secondary Outcomes (7)

  • Progression of HIV infection

  • CD4 cell count

  • Safety

  • Treatment adherence

  • Quality of life

  • +2 more secondary outcomes

Interventions

emtricitabine, FTC (drug)DRUG
didanosine, ddI (drug)DRUG
efavirenz (drug)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Maladies Infectieuses, Hôpital Saint-Louis

Paris, 75475, France

Location

Related Publications (2)

  • Gallien S, Journot V, Rozenbaum W, Yeni P, Morlat P, Poizot-Martin I, Reynes J, Reliquet V, Leclercq P, Simon F, Chene G, Molina JM; ALIZE (ANRS 099) Study Group. Four year follow-up of simplification therapy with once-daily emtricitabine, didanosine and efavirenz in HIV-infected patients (ALIZE ANRS 099 trial). J Antimicrob Chemother. 2011 Jan;66(1):184-91. doi: 10.1093/jac/dkq395. Epub 2010 Oct 28.

    PMID: 21036772RESULT

  • 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.

    PMID: 15717256RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

EmtricitabineRacivirPharmaceutical PreparationsDidanosineefavirenz

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesInosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDideoxynucleosidesRibonucleosides

Study Officials

  • Jean-Michel Molina, MD, PhD

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

    PRINCIPAL INVESTIGATOR

  • Genevieve Chene, MD, PhD

    INSERM unité 593, Bordeaux, France

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

April 1, 2001

Study Completion

September 1, 2004

Last Updated

June 15, 2026

Record last verified: 2026-06

Locations

FR(1)