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Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults

NCT00820118 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-04-07

No results posted yet for this study

Summary

The primary objective of the trial is to assess the ability of an early and intermittent antiretroviral therapy in maintaining an immunological stability in antiretroviral naive HIV infected adults, to offer a potential alternative strategy to differed and continuous antiretroviral treatment.This is a 2-year phase II, open-label, multicentric "proof of concept" trial. The patients included are treated following a pulse-therapy scheme, i.e. 6-month periods with once daily boosted-PI based therapy in alternance with 6-month periods without antiretroviral therapy. The preferentially recommended treatment of the study is atazanavir boosted with ritonavir, associated with a fixed combination of abacavir and lamivudine or emtricitabine + tenofovir.The patients are closely followed to assess the efficacy and the tolerance of the strategy, with clinical, biochemical, immunological, virological and pharmacokinetic evaluations.

Conditions

  • HIV Infections

Interventions

DRUG

Structured treatment interruption

The preferentially recommended treatment of the study is atazanavir boosted with ritonavir, associated with a fixed combination of abacavir and lamivudine or emtricitabine + tenofovir Usual dosage recommended : * atazanavir : 300 mg/d * ritonavir : 100 mg/d * abacavir 600 mg and lamivudine 300 mg : once a day * tenofovir 245 mg and emtricitabine 200 mg : once a day

Sponsors & Collaborators

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Lionel PIROTH, MD, PHD · Hôpital de Dijon, France

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00820118 on ClinicalTrials.gov