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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
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by MEDEX:

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).

Estimated Enrollment: 250
Study Start Date: April 2005
Estimated Study Completion Date: June 2008
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00199979     History of Changes
Other Study ID Numbers: DAUFIN
Study First Received: September 12, 2005
Last Updated: December 15, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Nevirapine
 Lamivudine
Tenofovir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 19, 2013