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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Para

Brief Summary: The purpose of this study is 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.

Detailed Summary:
Sponsor: AIDS Clinical Trials Group

Current Primary Outcome: Plasmodium falciparum (Pf) subclinical parasitemia (SCP) clearance [ Time Frame: Within 15 days of intervention initiation ]

Pf SCP clearance defined by PCR < 10 parasites/µL on three consecutive occasions within a 24-hour period


Original Primary Outcome: Plasmodium falciparum (Pf) subclinical parasitemia (SCP) clearance after 15 days of therapy [ Time Frame: Within 15 days ]

Pf SCP clearance defined by PCR < 10 parasites/µL on three consecutive occasions within a 24-hour period, within 15 days of intervention initiation.


Current Secondary Outcome:

  • Microscopy defined Pf SCP clearance (by batched centralized microscopy) defined by three consecutive negative blood samples [ Time Frame: Within 15 days of randomization ]
  • Time to confirmed Pf SCP clearance where confirmed clearance is defined by PCR < 10 parasites/µL on three consecutive occasions [ Time Frame: Within 15 days of intervention initiation ]
  • Both qualitative (yes/no) and quantitative (gametocytes/µL) Pf gametocyte carriage on Day 15 by PCR [ Time Frame: 15 days ]
  • Pf parasite density (parasites/µL) as determined by PCR on Day 15 [ Time Frame: 15 days ]
  • Uncomplicated clinical malaria at any time during the study [ Time Frame: Within 30 days ]
    Uncomplicated clinical malaria defined as the presence of non-severe fever/symptoms and parasitemia without organ complication (see section 7.1 of the protocol for more information)
  • LPV/r-related changes in sequence [ Time Frame: Within 30 days ]
    Plesmepsin sequences within Pf DNA extracted from selected stored dried blood spots may be sequenced to determine whether LPV/r-related changes in sequence occur


Original Secondary Outcome:

Information By: AIDS Clinical Trials Group

Dates:
Date Received: June 29, 2012
Date Started: July 2013
Date Completion:
Last Updated: April 14, 2017
Last Verified: April 2017