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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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 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

Drug Information available for: Zidovudine Nevirapine Lamivudine

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 (Adult, Senior)
Sexes Eligible for Study:	All
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

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

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

ClinicalTrials.gov processed this record on August 16, 2017

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