- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01772940
Nevirapine vs Ritonavir-boosted Lopinavir in ART Naive HIV-infected Adults in a Resource Limited Setting
Nevirapine vs Ritonavir-boosted Lopinavir in ART HIV-infected Adults in a Resource-limited Setting; a Randomized, Multicenter, Parallel Group Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Katanga
-
Lubumbashi, Katanga, Congo
- Cliniques Universitaires de Lubumbashi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 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
|
Nevirapine 200 mg twice daily or 400 mg once daily per os during 96 weeks
Other Names:
tenofovir 300 mg/emtricitabine 200 mg fixed-dose combination once daily, per os for 96 weeks
Other Names:
|
EXPERIMENTAL: 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
|
tenofovir 300 mg/emtricitabine 200 mg fixed-dose combination once daily, per os for 96 weeks
Other Names:
ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily per os during 96 weeks
Other Names:
|
ACTIVE_COMPARATOR: Nevirapine and zidovudine/lamivudine
nevirapine 200 mg/zidovudine 300 mg/lamivudine 150 mg (fixed-dose combination) twice daily, per os for 96 weeks
|
Nevirapine 200 mg twice daily or 400 mg once daily per os during 96 weeks
Other Names:
zidovudine 300 mg/lamivudine 150 mg twice daily fixed-dose generic combination, per os for 96 weeks
Other Names:
|
EXPERIMENTAL: 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
|
ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily per os during 96 weeks
Other Names:
zidovudine 300 mg/lamivudine 150 mg twice daily fixed-dose generic combination, per os for 96 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of therapeutic failure
Time Frame: At week 48 with follow-up until week 96
|
The primary end point is the proportion of patients with therapeutic failure defined as:
|
At week 48 with follow-up until week 96
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV-1 RNA viral load less than 50 copies/ml
Time Frame: Through week 96
|
The percentage of patients with HIV-1 RNA < 50 copies/ml
|
Through week 96
|
Immunologic response
Time Frame: Through week 96
|
Cluster of differentiation 4 (CD4) cell count change from baseline
|
Through week 96
|
HIV-1 resistance mutations
Time Frame: At baseline and at the time of virologic failure
|
At baseline and at the time of virologic failure
|
|
Safety and tolerability
Time Frame: Through week 96
|
Incidence of adverse events and laboratory abnormalities
|
Through week 96
|
Changes in laboratory parameters
Time Frame: Through week 96
|
Through week 96
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nathan Clumeck, MD, PhD, Centre Hospitalier Universitaire Saint Pierre
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Tenofovir
- Emtricitabine
- Nevirapine
- Ritonavir
- Lopinavir
- Lamivudine
- Zidovudine
Other Study ID Numbers
- Lubumbashi trial
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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