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Zidovudine / Lamivudine + Nevirapine Twice Daily, Versus Tenofovir + Lamivudine + Nevirapine Once Daily in ARV-Naive Patients

NCT ID: NCT00199979

Last Updated: 2005-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2008-06-30

Brief Summary

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The study will compare the immuno-virological efficacy, and safety, of a once daily antiretroviral combination (tenofovir + lamivudine + nevirapine) versus a twice daily association (fixed dose combination of zidovudine/lamivudine + nevirapine) in ARV-Naive HIV-1 infected subjects, with CD4 cell count below 350/µL or below 15%, whatever the viral load. Pharmacological (nevirapine concentrations) and virologic data (resistance mutations in case of failure) will also be provided, as well as adherence rate and quality of life in respect of the treatment arms.

Detailed Description

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96-week antiviral efficacy of tenofovir + lamivudine + nevirapine, once daily, versus a reference antiretroviral treatment given twice daily (zidovudine/lamivudine + nevirapine)

Conditions

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Hiv Infection With Antiretroviral Therapy Indication CD4 Below 350/µL or Below 15%

Keywords

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Antiretroviral Therapy Nevirapine HIV Viral Load Adherence Quality of Life Resistance Mutations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Nevirapine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HIV-1 infection, confirmed by a western-blot assay, at least 6 months after primary infection
* Age \> or equal to 18 years of age
* No prior antiretroviral treatment
* Karnofsky superior to 60%
* CD4 T cells \< 350/µL (2 measures, with at least a 1-month interval) in women, study will be proposed when CD4 cell count is below 250/µL, as nevirapine liver toxicity increases (X10) when CD4 are \> 250/µL
* Written informed consent

Exclusion Criteria

* HIV-2 infection or co-infection
* Prior antiretroviral treatment
* Intolerance, or contraindication to investigational drugs
* Pregnant or breast-feeding woman, or plan to become pregnant
* Active untreated opportunistic infections (AIDS-defining illness, category C, CDC, 1993), or malignancies requiring cytotoxic chemotherapy
* Biological criteria: hemoglobin \< 10 G/DL, neutrophil count \< 1000/µL, platelets \< 50000/µL, creatinine \> 2N, ASAT or ALAT \> 2.5N, bilirubin \> 2N, hypophosphatemia
* Prevision of poor adherence
* HBC co-infection (Ag Hbs positive) or HVC co-infection (positive HCV PCR)
* Liver failure, alcohol abuse
* Treatment administration not recommended with investigational drugs
* Interferon, interleukin, or HIV vaccine treatment
* Informed consent not obtained
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MEDEX

OTHER

Sponsor Role lead

Principal Investigators

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REY MR DAVID, M.D

Role: PRINCIPAL_INVESTIGATOR

CISIH CHRU STRASBOURG

Locations

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Cisih, Clinique Medical A, Hopitaux Universitaires

Strasbourg, Alsace, France

Site Status RECRUITING

Countries

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France

Central Contacts

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REY DAVID, M.D

Role: CONTACT

Phone: 0388116451

Email: [email protected]

LARGUIER JEAN-SYLVAIN, M.D

Role: CONTACT

Phone: 0437451717

Email: [email protected]

Facility Contacts

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REY DAVID, M.D

Role: primary

Other Identifiers

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DAUFIN

Identifier Type: -

Identifier Source: org_study_id