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

C

Centre Hospitalier Universitaire Saint Pierre

Status and phase

Completed
Phase 4

Conditions

HIV-1 Infection

Treatments

Drug: Tenofovir/emtricitabine
Drug: ritonavir-boosted Lopinavir
Drug: nevirapine
Drug: Zidovudine/lamivudine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01772940
Lubumbashi trial

Details and patient eligibility

About

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.

Enrollment

425 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

425 participants in 4 patient groups

nevirapine and tenofovir/emtricitabine
Active Comparator group
Description:
nevirapine 200 mg twice daily combined with tenofovir 300 mg/emtricitabine 200 mg (fixed-dose combination) once daily, per os for 96 weeks
Treatment:
Drug: nevirapine
Drug: Tenofovir/emtricitabine
lopinavir/r and tenofovir/emtricitabine
Experimental group
Description:
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
Treatment:
Drug: ritonavir-boosted Lopinavir
Drug: Tenofovir/emtricitabine
Nevirapine and zidovudine/lamivudine
Active Comparator group
Description:
nevirapine 200 mg/zidovudine 300 mg/lamivudine 150 mg (fixed-dose combination) twice daily, per os for 96 weeks
Treatment:
Drug: Zidovudine/lamivudine
Drug: nevirapine
Lopinavir/r and zidovudine/lamivudine
Experimental group
Description:
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
Treatment:
Drug: Zidovudine/lamivudine
Drug: ritonavir-boosted Lopinavir

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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