Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults

HIV Infections Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820118
• Other study ID #: ANRS 141 TIPI
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2009
• Last updated: May 22, 2012
• Start date: May 2009
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
France	Services maladies infectieuses et tropicales CHU	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		M21 and M24	No
Secondary	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		M12 and M24	Yes
Secondary	number, type and time to AIDS and non AIDS-related serious clinical events		from week 0 to M24	Yes
Secondary	number, type and time to clinical and biological events (whatever the grade of severity)		from week 0 to M24	Yes
Secondary	existence and nature of HIV genotypic mutations associated with antiretroviral resistance		M9 and M24 and at any time visit in case of failure	Yes
Secondary	proportion of patients having followed the strategy of the trial		from week 0 to M24	No
Secondary	evolution of HIV RNA and HIV DNA throughout the study		from week 0 to M24 for RNA and each 6 months for DNA	No
Secondary	Quality of life and observance (questionnaires)		QL each 6 months, observance at M1, M6, M13 and M18	No

External Links

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