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

HIV-1 Infection Clinical Trial

Official title:

Nevirapine vs Ritonavir-boosted Lopinavir in ART HIV-infected Adults in a Resource-limited Setting; a Randomized, Multicenter, Parallel Group Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772940
• Other study ID #: Lubumbashi trial
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2013
• Last updated: August 22, 2013
• Start date: December 2008
• Est. completion date: December 2011

Study information

• Verified date: August 2013
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Drug:
• nevirapine
Nevirapine 200 mg twice daily or 400 mg once daily per os during 96 weeks
• ritonavir-boosted Lopinavir
ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily per os during 96 weeks
• Tenofovir/emtricitabine
tenofovir 300 mg/emtricitabine 200 mg fixed-dose combination once daily, per os for 96 weeks
• Zidovudine/lamivudine
zidovudine 300 mg/lamivudine 150 mg twice daily fixed-dose generic combination, per os for 96 weeks

Locations

Country	Name	City	State
Congo	Cliniques Universitaires de Lubumbashi	Lubumbashi	Katanga

Sponsors (7)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre	Abbott, Gilead Sciences, Ministry of Public Health, Democratic Republic of the Congo, Pierre and Marie Curie University, University Hospital of Liege, University Paris 7 - Denis Diderot

Country where clinical trial is conducted

Congo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of therapeutic failure	The primary end point is the proportion of patients with therapeutic failure defined as: the occurence or relapse by week 24 of a World Health Organization (WHO) stage 4 or 3 event, or; death by week 24, or; discontinuation of study drugs due to toxicity at any time, or; virological failure defined as HIV-1 RNA > 1000 copies/ml by week 24	At week 48 with follow-up until week 96	Yes
Secondary	HIV-1 RNA viral load less than 50 copies/ml	The percentage of patients with HIV-1 RNA < 50 copies/ml	Through week 96	No
Secondary	Immunologic response	Cluster of differentiation 4 (CD4) cell count change from baseline	Through week 96	No
Secondary	HIV-1 resistance mutations		At baseline and at the time of virologic failure	No
Secondary	Safety and tolerability	Incidence of adverse events and laboratory abnormalities	Through week 96	Yes
Secondary	Changes in laboratory parameters		Through week 96	No