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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hiv Infection With Antiretroviral Therapy Indication CD4 Below 350/µL or Below 15% | Drug: Nevirapine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
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 |
Study Completion Date : | June 2008 |

- 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).

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

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
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 | |
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 |
Principal Investigator: | REY MR DAVID, M.D | CISIH CHRU STRASBOURG |
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 |