Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults - Full Text View

Sponsor:	French National Agency for Research on AIDS and Viral Hepatitis
Information provided by:	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT00820118

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Structured treatment interruption	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: BMS 232632 Atazanavir sulfate

U.S. FDA Resources

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

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. [ Time Frame: M21 and M24 ] [ Designated as safety issue: No ]

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 [ Time Frame: M12 and M24 ] [ Designated as safety issue: Yes ]
number, type and time to AIDS and non AIDS-related serious clinical events [ Time Frame: from week 0 to M24 ] [ Designated as safety issue: Yes ]
number, type and time to clinical and biological events (whatever the grade of severity) [ Time Frame: from week 0 to M24 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
proportion of patients having followed the strategy of the trial [ Time Frame: from week 0 to M24 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Quality of life and observance (questionnaires) [ Time Frame: QL each 6 months, observance at M1, M6, M13 and M18 ] [ Designated as safety issue: No ]

Estimated Enrollment:	39
Study Start Date:	May 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Intermittent treatment: Experimental 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

Arms

Assigned Interventions

Intermittent treatment: Experimental

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820118

Contacts

Contact: Lionel PIROTH, MD, PHD

+33380293305

lionel.piroth@chu-dijon.fr

Locations

France
Services maladies infectieuses et tropicales CHU	Recruiting
DIJON, France
Contact: Lionel PIROTH, MD, PHD
Principal Investigator: Lionel PIROTH, MD, PHD

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

Investigators

Principal Investigator:

Lionel PIROTH, MD, PHD

Hôpital de Dijon, France

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	French National Agency for Research on AIDS and Viral Hepatitis ( French National Agency for Research on AIDS and Viral Hepatitis )
Study ID Numbers:	ANRS 141 TIPI
Study First Received:	January 8, 2009
Last Updated:	June 9, 2009
ClinicalTrials.gov Identifier:	NCT00820118 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

ANTIRETROVIRAL THERAPY
STRUCTURED TREATMENT INTERRUPTIONS
treatment naive

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010