NCT00820118

Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults

ARNS 141 TIPI : A Pilot Trial to Assess the Ability of an Intermittent Antiretroviral Therapy in Maintaining an Immunological Stability in Antiretroviral naïve HIV Infected Adults, With CD4 Count Above 500/mm3

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2009-01-09
• Last updated: 2026-04-07

Locations

1 site across 1 country: France