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Nevirapine vs Ritonavir-boosted Lopinavir in ART Naive HIV-infected Adults in a Resource Limited Setting

NCT ID: NCT01772940

Last Updated: 2013-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

425 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-12-31

Brief Summary

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In resource-limited setting, concerns remain regarding the emergence of virologic failure and high-level drug resistance mutations (DRM) during WHO recommended first-line antiretroviral therapy (ART) with non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens for Human immunodeficiency virus 1 (HIV1) infected patients. The study hypothesis is that a boosted-protease inhibitor regimen has a better outcome than a NNRTI-based regimen with a low genetic barrier to resistance.

The study is a randomized, multicenter, factorial trial (conducted in Congo), in treatment- naïve adults receiving for 96 weeks ritonavir- boosted lopinavir(LPV/r) or nevirapine (NVP) each in combination with tenofovir (TDF) /emtricitabine (FTC) or zidovudine (ZDV)/lamivudine (3TC). The primary end point is the incidence of therapeutic (clinical and/or virologic)failure by study week 24.

Detailed Description

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Conditions

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HIV-1 Infection

Keywords

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First-line therapy Protease inhibitor Non-Nucleoside Reverse transcriptase Inhibitor Resource-limited setting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nevirapine and tenofovir/emtricitabine

nevirapine 200 mg twice daily combined with tenofovir 300 mg/emtricitabine 200 mg (fixed-dose combination) once daily, per os for 96 weeks

Group Type ACTIVE_COMPARATOR

nevirapine

Intervention Type DRUG

Nevirapine 200 mg twice daily or 400 mg once daily per os during 96 weeks

Tenofovir/emtricitabine

Intervention Type DRUG

tenofovir 300 mg/emtricitabine 200 mg fixed-dose combination once daily, per os for 96 weeks

lopinavir/r and tenofovir/emtricitabine

ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily combined with tenofovir 300 mg/emtricitabine 200 mg (fixed-dose combination) once daily, per os for 96 weeks

Group Type EXPERIMENTAL

ritonavir-boosted Lopinavir

Intervention Type DRUG

ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily per os during 96 weeks

Tenofovir/emtricitabine

Intervention Type DRUG

tenofovir 300 mg/emtricitabine 200 mg fixed-dose combination once daily, per os for 96 weeks

Nevirapine and zidovudine/lamivudine

nevirapine 200 mg/zidovudine 300 mg/lamivudine 150 mg (fixed-dose combination) twice daily, per os for 96 weeks

Group Type ACTIVE_COMPARATOR

nevirapine

Intervention Type DRUG

Nevirapine 200 mg twice daily or 400 mg once daily per os during 96 weeks

Zidovudine/lamivudine

Intervention Type DRUG

zidovudine 300 mg/lamivudine 150 mg twice daily fixed-dose generic combination, per os for 96 weeks

Lopinavir/r and zidovudine/lamivudine

ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg once daily combined with zidovudine 300 mg/lamivudine 150 mg once daily, per os for 96 weeks

Group Type EXPERIMENTAL

ritonavir-boosted Lopinavir

Intervention Type DRUG

ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily per os during 96 weeks

Zidovudine/lamivudine

Intervention Type DRUG

zidovudine 300 mg/lamivudine 150 mg twice daily fixed-dose generic combination, per os for 96 weeks

Interventions

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nevirapine

Nevirapine 200 mg twice daily or 400 mg once daily per os during 96 weeks

Intervention Type DRUG

ritonavir-boosted Lopinavir

ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily per os during 96 weeks

Intervention Type DRUG

Tenofovir/emtricitabine

tenofovir 300 mg/emtricitabine 200 mg fixed-dose combination once daily, per os for 96 weeks

Intervention Type DRUG

Zidovudine/lamivudine

zidovudine 300 mg/lamivudine 150 mg twice daily fixed-dose generic combination, per os for 96 weeks

Intervention Type DRUG

Other Intervention Names

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Viramune Aluvia Truvada Zidolam,combivir

Eligibility Criteria

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Inclusion Criteria

* Antiretroviral-therapy naïve HIV-1 infected Adults
* WHO clinical stage 3 and CD4 \<350/mm3 or
* WHO clinical stage 4 or
* CD4 cell count \< 200/mm3
* Negative pregnancy test

Exclusion Criteria

* Hemoglobin \< 8.5 g/dL (female) or 9.0 g/dL (male)
* Estimated Glomerular Filtration Rate \< 50 ml/ minute (Cockcroft-Gault equation)
* Hepatic transaminases (AST and ALT)\> 3 x upper limit of normal
* Active tuberculosis
* Pregnancy
* Females who are breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role collaborator

Ministry of Public Health, Democratic Republic of the Congo

OTHER_GOV

Sponsor Role collaborator

Pierre and Marie Curie University

OTHER

Sponsor Role collaborator

University Paris 7 - Denis Diderot

OTHER

Sponsor Role collaborator

Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role collaborator

Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role lead

Responsible Party

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Clumeck Nathan

Chief infectious diseases , Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nathan Clumeck, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Saint Pierre

Locations

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Cliniques Universitaires de Lubumbashi

Lubumbashi, Katanga, Republic of the Congo

Site Status

Countries

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Republic of the Congo

References

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Clumeck N, Mwamba C, Kabeya K, Matanda S, Vaira D, Necsoi C, Kadiebwe D, Delforge M, Kasamba E, Milolo C, Ilunga J, Kapend L. First-line antiretroviral therapy with nevirapine versus lopinavir-ritonavir based regimens in a resource-limited setting. AIDS. 2014 May 15;28(8):1143-53. doi: 10.1097/QAD.0000000000000214.

Reference Type DERIVED
PMID: 25028911 (View on PubMed)

Other Identifiers

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Lubumbashi trial

Identifier Type: -

Identifier Source: org_study_id