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
Recruitment status was Recruiting
Sponsor:
MEDEX
Information provided by:
MEDEX
ClinicalTrials.gov Identifier:
NCT00199979
First received: September 12, 2005
Last updated: December 15, 2005
Last verified: September 2005
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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:
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 |
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 (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199979
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
| 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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Zidovudine Nevirapine Lamivudine |
Tenofovir Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |
ClinicalTrials.gov processed this record on September 30, 2016