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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Structured treatment interruption

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring ANTIRETROVIRAL THERAPY, STRUCTURED TREATMENT INTERRUPTIONS, treatment naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Services maladies infectieuses et tropicales CHU

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intermittent treatment

Arm Description

6 months on antiretroviral treatment and 6 months off treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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

existence and nature of HIV genotypic mutations associated with antiretroviral resistance

proportion of patients having followed the strategy of the trial

evolution of HIV RNA and HIV DNA throughout the study

Quality of life and observance (questionnaires)

Full Information

NCT ID

NCT00820118

First Posted

January 8, 2009

Last Updated

May 22, 2012

Sponsor

ANRS, Emerging Infectious Diseases

1. Study Identification

Unique Protocol Identification Number

NCT00820118

Brief Title

Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults

Acronym

TIPI

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ANRS, Emerging Infectious Diseases

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

ANTIRETROVIRAL THERAPY, STRUCTURED TREATMENT INTERRUPTIONS, treatment naive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intermittent treatment

Arm Type

Experimental

Arm Description

6 months on antiretroviral treatment and 6 months off treatment

Intervention Type

Drug

Intervention Name(s)

Structured treatment interruption

Other Intervention Name(s)

Reyataz, Truvada, Kivexa, Treatment interruption, STI

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Title

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

Time Frame

from week 0 to M24

Title

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

Time Frame

from week 0 to M24

Title

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

Title

proportion of patients having followed the strategy of the trial

Time Frame

from week 0 to M24

Title

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

Title

Quality of life and observance (questionnaires)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lionel PIROTH, MD, PHD

Organizational Affiliation

Hôpital de Dijon, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Services maladies infectieuses et tropicales CHU

City

Dijon

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

26568566

Citation

Piroth L, Moinot L, Yeni P, Avettand-Fenoel V, Reynes J, Girard PM, Marchou B, Georget A, Rouzioux C, Autran B, Duvillard L, Chene G, Fagard C; ANRS 141 TIPI Trial Study Group. Immunity, inflammation and reservoir in patients at an early stage of HIV infection on intermittent ART (ANRS 141 TIPI Trial). J Antimicrob Chemother. 2016 Feb;71(2):490-6. doi: 10.1093/jac/dkv369. Epub 2015 Nov 14.

Results Reference

derived

Links:

URL

http://www.anrs.fr

Description

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Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults

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