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Completed

NCT Number: NCT00820118

Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults

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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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Services maladies infectieuses et tropicales CHU

Dijon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured treatment interruption

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

Other names: Reyataz, Truvada, Kivexa, Treatment interruption, STI

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. number, type and time to AIDS and non AIDS-related serious clinical events

    Time frame: from week 0 to M24

  3. number, type and time to clinical and biological events (whatever the grade of severity)

    Time frame: from week 0 to M24

  4. 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

  5. proportion of patients having followed the strategy of the trial

    Time frame: from week 0 to M24

  6. 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

  7. Quality of life and observance (questionnaires)

    Time frame: QL each 6 months, observance at M1, M6, M13 and M18

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Official study title

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

Acronym: TIPI

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 9, 2009
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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