HIV-1 Infection Clinical Trial
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 Parasitemia in HIV-infected Adults With CD4+ Counts >200 and <500 Cells/mm^3
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.
A5297 was a Phase I/II, open-label, proof of concept, two-step, two-arm, randomized
controlled 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).
The study consisted of two steps. At study Step 1 entry, participants were randomized 1:1 to
either LPV/r-based ART or nNRTI-based ART for 15 days. In study Step 2, all participants
received nNRTI-based ART and TMP/SMX prophylaxis for 15 days. The total study duration was 30
days.
Study visits occurred every 3 days in Step 1, and every 5 days in Step 2. At each study
visit, 2 samples were taken for measurement of parasite density, except day 15 and day 30 at
which 3 samples were taken.
Adverse events which occurred after randomization were also recorded. Signs/symptoms and
diagnoses were evaluated at each visit, while safety labs (including Hemoglobin, hematocrit,
white blood cell count (WBC), differential WBC, platelet count, and absolute neutrophil count
(ANC), glucose, electrolytes (sodium, potassium, chloride, bicarbonate), total bilirubin, AST
(SGOT), ALT (SGPT), albumin, alkaline phosphatase, and creatinine) were taken at day 15 and
day 30, or if indicated at other study visits.
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