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

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ClinicalTrials.gov Identifier: NCT00199979
Recruitment Status : Unknown
Verified September 2005 by MEDEX.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : December 16, 2005
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Hiv Infection With Antiretroviral Therapy Indication CD4 Below 350/µL or Below 15% Drug: Nevirapine Phase 3

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2005
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199979


Contacts
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

Locations
France
Cisih, Clinique Medical A, Hopitaux Universitaires Recruiting
Strasbourg, Alsace, France, 67091
Contact: REY DAVID, M.D    0388116333 ext 33    david.rey@chru-strasbourg.fr   
Principal Investigator: REY DAVID, M.D         
Sponsors and Collaborators
MEDEX
Investigators
Principal Investigator: REY MR DAVID, M.D CISIH CHRU STRASBOURG
More Information

ClinicalTrials.gov Identifier: NCT00199979     History of Changes
Other Study ID Numbers: DAUFIN
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 16, 2005
Last Verified: September 2005

Keywords provided by MEDEX:
Antiretroviral Therapy
Nevirapine
HIV Viral Load
Adherence
Quality of Life
Resistance Mutations

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Lamivudine
Zidovudine
Nevirapine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Antimetabolites
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers