DESIGN                      A5297 is a phase I/II, open-label, proof of concept, two-step, two-arm, controlled randomized clinical trial (RCT) to test the superiority of lopinavir/ritonavir (LPV/r)-based antiretroviral therapy (ART) to non-nucleoside reverse transcriptase (nNRTI)-based ART for clearance of Plasmodium falciparum (Pf) subclinical parasitemia (SCP). 

Participants will be followed for 30 days in order to evaluate parasitemia clearance, Pf parasitemia, gametocytemia, and plasmepsin sequencing.  Participants will have blood collected twice at entry, day 3, 6, 9, 12, 20, and 25 and three times for day 15 and day 30. Therefore, on most study days, participants will need to either remain at the clinic for an extended period of time or be willing to return two or three times at approximately 8-hour intervals (see section 6.2 for details).

DURATION                30 days:  Step 1= days 1-15; Step 2= days 16-30

SAMPLE SIZE            52 participants

POPULATION            HIV infected adults at least 18 years of age with CD4+ counts >200 and < 350 cells/mm³ who will be starting ART and have Pf SCP.  Individuals with signs or symptoms suggestive of concurrent opportunistic infections, pulmonary or gastrointestinal infections, or clinical malaria will be excluded.

REGIMENS                Step 1

Participants will be randomized 1:1 to one of the following arms for 15 days: 

                                    Arm A: LPV/r-based ART

Arm B: nNRTI-based ART

Step 2

All participants will receive an nNRTI-based ART and TMP/SMX prophylaxis to take from day 16 through day 30.