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

Primary Purpose

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

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Nevirapine
Sponsored by
MEDEX
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hiv Infection With Antiretroviral Therapy Indication focused on measuring Antiretroviral Therapy, Nevirapine, HIV Viral Load, Adherence, Quality of Life, Resistance Mutations

Eligibility Criteria

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

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

Sites / Locations

  • Cisih, Clinique Medical A, Hopitaux UniversitairesRecruiting

Outcomes

Primary Outcome Measures

To compare the antiviral efficacy of AZT, 3TC, and NVP combination, in two doses per day, to the association of TDF, 3TC, and NVP, once a day, in antiretroviral naive HIV-1-infected patients (plasma viral load below 400 copies/ml at 96 weeks).

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
December 15, 2005
Sponsor
MEDEX
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1. Study Identification

Unique Protocol Identification Number
NCT00199979
Brief Title
Zidovudine / Lamivudine + Nevirapine Twice Daily, Versus Tenofovir + Lamivudine + Nevirapine Once Daily in ARV-Naive Patients
Official Title
Multicenter, Randomized, Open-Label Trial, Assessing the Efficacy of Zidovudine, Lamivudine and Nevirapine Combination Administered Twice Daily, Versus the Association of Tenofovir, Lamivudine and Nevirapine, Once Daily, in Antiretroviral Naive HIV-1 Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
MEDEX

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv Infection With Antiretroviral Therapy Indication, CD4 Below 350/µL or Below 15%
Keywords
Antiretroviral Therapy, Nevirapine, HIV Viral Load, Adherence, Quality of Life, Resistance Mutations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nevirapine
Primary Outcome Measure Information:
Title
To compare the antiviral efficacy of AZT, 3TC, and NVP combination, in two doses per day, to the association of TDF, 3TC, and NVP, once a day, in antiretroviral naive HIV-1-infected patients (plasma viral load below 400 copies/ml at 96 weeks).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
REY DAVID, M.D
Phone
0388116451
Ext
33
Email
david.rey@chru-strasbourg.fr
First Name & Middle Initial & Last Name or Official Title & Degree
LARGUIER JEAN-SYLVAIN, M.D
Phone
0437451717
Ext
33
Email
daufin@rcts.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
REY MR DAVID, M.D
Organizational Affiliation
CISIH CHRU STRASBOURG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cisih, Clinique Medical A, Hopitaux Universitaires
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
REY DAVID, M.D
Phone
0388116333
Ext
33
Email
david.rey@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
REY DAVID, M.D

12. IPD Sharing Statement

Learn more about this trial

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

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