Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults (TIPI)

April 2, 2026 updated by: ANRS, Emerging Infectious Diseases

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France
        • Services maladies infectieuses et tropicales CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intermittent treatment
6 months on antiretroviral treatment and 6 months off treatment
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
Other Names:
  • Truvada
  • Reyataz
  • Kivexa
  • Treatment interruption
  • STI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proportion of patients with mean CD4 count at M21 and M24 above or equal to the mean CD4 count at screening and inclusion, without experiencing a decrease below 400/mm3 throughout the study.
Time Frame: M21 and M24
M21 and M24

Secondary Outcome Measures

Outcome Measure
Time Frame
proportion of patients following the strategy of the trial and with AIDS related and non AIDS-related (cardiovascular, renal, hepatic, infectious, cancerous) serious clinical event
Time Frame: M12 and M24
M12 and M24
number, type and time to AIDS and non AIDS-related serious clinical events
Time Frame: from week 0 to M24
from week 0 to M24
number, type and time to clinical and biological events (whatever the grade of severity)
Time Frame: from week 0 to M24
from week 0 to M24
existence and nature of HIV genotypic mutations associated with antiretroviral resistance
Time Frame: M9 and M24 and at any time visit in case of failure
M9 and M24 and at any time visit in case of failure
proportion of patients having followed the strategy of the trial
Time Frame: from week 0 to M24
from week 0 to M24
evolution of HIV RNA and HIV DNA throughout the study
Time Frame: from week 0 to M24 for RNA and each 6 months for DNA
from week 0 to M24 for RNA and each 6 months for DNA
Quality of life and observance (questionnaires)
Time Frame: QL each 6 months, observance at M1, M6, M13 and M18
QL each 6 months, observance at M1, M6, M13 and M18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Investigators

  • Principal Investigator: Lionel PIROTH, MD, PHD, Hôpital de Dijon, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (Estimated)

January 9, 2009

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 141 TIPI
  • 2008-004885-24 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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