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

NCT00199979 | Unknown Phase 3

• 1 other identifier: DAUFIN
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (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).

Interventions

Nevirapine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MEDEX: lead

Study Sites (1)

Cisih, Clinique Medical A, Hopitaux Universitaires

Strasbourg, Alsace, 67091, France

RECRUITING

MeSH Terms

Interventions

Nevirapine

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• REY MR DAVID, M.D

  CISIH CHRU STRASBOURG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

REY DAVID, M.D

CONTACT

0388116451; david.rey@chru-strasbourg.fr

LARGUIER JEAN-SYLVAIN, M.D

CONTACT

0437451717; daufin@rcts.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: April 1, 2005
• Study Completion: June 1, 2008
• Last Updated: December 16, 2005

Record last verified: 2005-09

Locations

FR (1)