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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00199979

Enrollment

250

Registered

2005-09-20

Start date

2005-04-30

Completion date

2008-06-30

Last updated

2005-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Antiretroviral Therapy, Nevirapine, HIV Viral Load, Adherence, Quality of Life, Resistance Mutations

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)

Interventions

DRUGNevirapine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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).	—

Countries

France

Contacts

Primary ContactREY DAVID, M.D

david.rey@chru-strasbourg.fr0388116451

Backup ContactLARGUIER JEAN-SYLVAIN, M.D

daufin@rcts.fr0437451717

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026