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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by MEDEX.
Recruitment status was Recruiting

Sponsor:

Information provided by:

MEDEX

ClinicalTrials.gov Identifier:

NCT00199979

First received: September 12, 2005

Last updated: December 15, 2005

Last verified: September 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

December 15, 2005

Start Date ^ICMJE

April 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00199979 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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)

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: Nevirapine

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

250

Completion Date

June 2008

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: REY DAVID, M.D	0388116451 ext 33	david.rey@chru-strasbourg.fr
Contact: LARGUIER JEAN-SYLVAIN, M.D	0437451717 ext 33	daufin@rcts.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00199979

Other Study ID Numbers ^ICMJE

DAUFIN

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

MEDEX

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

REY MR DAVID, M.D

CISIH CHRU STRASBOURG

Information Provided By

MEDEX

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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