Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intermittent treatment

6 months on antiretroviral treatment and 6 months off treatment

Group Type EXPERIMENTAL

Structured treatment interruption

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Reyataz Truvada Kivexa Treatment interruption STI

Eligibility Criteria

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Inclusion Criteria

* adult confirmed HIV-1 infection
* no previous treatment with antiretroviral drugs or interleukin-2
* CD4 count ≥ 500/mm3
* no active opportunistic infection
* written informed consent

Exclusion Criteria

* non barrier contraception in women of child bearing potential, pregnant or breastfeeding woman, pregnancy project within the next 2 years
* HIV-2 infection (with or without HIV-1), recent HIV primary infection, resistance to trial drugs at study entry, Ag HBs+, HCV requiring specific therapy
* previous history of cerebrovascular accident or coronary heart disease, splenectomy
* previous CD4 count \< 400/mm3
* CD4 percentage \< 15%
* hemoglobin \< 8 g/dl, neutrophils \< 750/mm3, platelets \< 100.000/mm3, creatinine clearance \< 50 ml/mn, AST or ALT or total bilirubin \> 3 ULN

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No