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Comparing PI-Based to a nNRTI-based ART for Clearance of Plasmodium Falciparum Parasitemia in HIV-Infected

NCT01632891 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2019-08-06

Study results available
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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.

Conditions

  • HIV-1 Infection
  • Pf Subclinical Parasitemia

Interventions

DRUG

Lopinavir/ritonavir

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

DRUG

Emtricitabine/tenofovir disoproxil fumarate

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

DRUG

Efavirenz

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

DRUG

Nevirapine

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

DRUG

Trimethoprim/sulfamethoxazole

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    lead NETWORK

Principal Investigators

  • Johnstone Kumwenda, FRCP · College of Medicine-Johns Hopkins Project

  • Douglas Shaffer, MD, MHS · Kenya Medical Research Institute/Walter Reed Project

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-10
Primary Completion
2016-06-19
Completion
2016-06-19

Countries

  • Kenya
  • Malawi
  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01632891 on ClinicalTrials.gov