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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00196612

Enrollment

350

Registered

2005-09-20

Start date

2001-04-01

Completion date

2004-09-01

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV Infections, Reverse Transcriptase Inhibitors, Treatment simplification

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.

Interventions

DRUGemtricitabine, FTC (drug)

DRUGdidanosine, ddI (drug)

DRUGefavirenz (drug)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Virological success from W0 to W48	—

Secondary

Measure	Time frame
Progression of HIV infection	—
CD4 cell count	—
Safety	—
Treatment adherence	—
Quality of life	—
Viral mutations	—
Therapeutic strategy failure	—

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJean-Michel Molina, MD, PhD

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

STUDY_DIRECTORGenevieve Chene, MD, PhD

INSERM unité 593, Bordeaux, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026