CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
Lopinavir/ritonavir +4 moredrug
Likely dose
Lopinavir/ritonavir 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01632891
NCT01632891Phase 2Completed

An Open-Label, Proof of Concept, Randomized Trial Comparing a LPV/r-Based to an nNRTI-Based Antiretroviral Therapy Regimen for Clearance of Plasmodium Falciparum Subclinical Parasitemia in HIV-infected Adults With CD4+ Counts >200 and <500 Cells/mm^3

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·interventional·Posted Jul 3, 2012·Updated Aug 6, 2019

In Brief

A Phase 2 clinical trial evaluating Lopinavir/ritonavir, Emtricitabine/tenofovir disoproxil fumarate, and 3 other interventions for HIV-1 Infection and Pf Subclinical Parasitemia. Completed, enrolled 52 participants across 5 sites in 3 countries.

Detailed Summary

The purpose of this study was to see if antiretroviral therapy (ART) is safe and works at getting rid of malaria in blood and to see whether one type of ART is better than another. This study may offer information for further research in looking at whether ART plays a role in the prevention and treatment of malaria.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesKenya, Malawi, Uganda

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 3, 2012
Enrollment StartJan 10, 2014
Primary CompletionJun 19, 2016
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 14.0 years ago

Interventions

Lopinavir/ritonavirdrug

Participants received two 200 mg/50 mg tablets of lopinavir/ritonavir orally twice daily.

Emtricitabine/tenofovir disoproxil fumaratedrug

Participants received one 200 mg/300 mg tablet of Emtricitabine/tenofovir disoproxil fumarate orally once daily.

Efavirenzdrug

Participants received one 600 mg tablet of efavirenz orally once daily.

Nevirapinedrug

If unable to take efavirenz, participants received on 200 mg tablet of nevirapine orally once daily.

Trimethoprim/sulfamethoxazoledrug

Participants received one 160 mg/800 mg tablet of trimethoprim/sulfamethoxazole orally once daily.