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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

September 12, 2005
December 15, 2005
April 2005
Not Provided
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).
Same as current
Complete list of historical versions of study NCT00199979 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Zidovudine / Lamivudine + Nevirapine Twice Daily, Versus Tenofovir + Lamivudine + Nevirapine Once Daily in ARV-Naive Patients
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

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hiv Infection With Antiretroviral Therapy Indication
  • CD4 Below 350/µL or Below 15%
Drug: Nevirapine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
June 2008
Not Provided

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
Both
18 Years and older
No
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
France
 
NCT00199979
DAUFIN
Not Provided
Not Provided
MEDEX
Not Provided
Principal Investigator: REY MR DAVID, M.D CISIH CHRU STRASBOURG
MEDEX
September 2005

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