Participants were prescribed to LPV/r-based antiretroviral therapy (ART) for 15 days, which includes lopinavir/ritonavir plus emtricitabine/tenofovir disoproxil fumarate; followed by an nNRTI-based ART, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.

Participants were prescribed to nNRTI-based ART for 15 days, which includes efavirenz, nevirapine, plus emtricitabine/tenofovir disoproxil fumarate, followed by an nNRTI-based ART and Trimethoprim/sulfamethoxazole prophylaxis to take from day 16 through day 30.

LPV/R-based ART

nNRTI-based ART

Total

Sex: Female, Male

Race/Ethnicity, Customized

Region of Enrollment

CD4 cell count

Log10(HIV-1 RNA)

Log10(parasite density)

Pf SCP clearance defined by polymerase chain reaction (PCR) < 10 parasites/µL on three consecutive occasions within a 24-hour period.
If a participant had missing data on day 15, they were considered as not having clearance.

Proportion of Participants With Plasmodium Falciparum (Pf) Subclinical Parasitemia (SCP) Clearance

Time to clearance is defined by time to first measurement with PCR < 10 parasites/µL, and is evaluated as the point estimate and 95% CI for the day when 50% of participants cleared parasite.

Time to First Pf SCP Clearance

Pf parasite density was determined by PCR. If parasite density equals 0, the value is set to 0.01 before log10 transformation. The value 0.01 was chosen based on the smallest observed parasite density value of 0.017.

Log10(Pf Parasite Density)

Change is evaluated as log10(Pf parasite density) at day 30 minus log10(Pf parasite density) at entry.
Change is evaluated in four groups:
Randomized to nNRTI-based ART with continued Pf SCP at day 15
Randomized to nNRTI-based ART with clearance of Pf SCP at day 15
Randomized to LPV/r-based ART with continued Pf SCP at day 15
Randomized to LPV/r-based ART with clearance of Pf SCP at day 15

Randomized to nNRTI based ART with continued Pf SCP at day 15

nNRTI-based ART, Not Cleared

Randomized to nNRTI based ART with clearance of Pf SCP at day 15

nNRTI-based ART, Cleared

Randomized to LPV/r based ART with continued Pf SCP at day 15

LPV/R-based ART, Not Cleared

Randomized to LPV/r based ART with clearance of Pf SCP at day 15

LPV/R-based ART, Cleared

Change in log10(Pf Parasite Density) From Entry to Day 30

Uncomplicated clinical malaria is defined as the presence of non-severe fever/symptoms and parasitemia without organ complication.

Number of Participants With Uncomplicated Clinical Malaria

Number of participants with detectable Pf gametocyte density as determined by PCR. Due to the large number of undetectable results, this outcome was measured as dichotomous.

Number of Participants With Detectable Pf Gametocyte Density

Change in log10(Pf gametocyte density) as evaluated using a Hodges-Lehmann estimate from entry to day 30 is evaluated in two groups:
Randomized to nNRTI-based ART with continued Pf SCP at day 15
Randomized to LPV/r-based ART with continued Pf SCP at day 15
Analysis was not conducted in either group with clearance at day 15 due to the small sample size and high number of undetectable samples in both clearance groups at entry and day 30.

Change in log10(Pf Gametocyte Density) From Entry to Day 30

Overall Study

ACTG Clinicaltrials.gov Coordinator

HIV-1 Infection

Pf Subclinical Parasitemia

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

Lopinavir/ritonavir

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

Emtricitabine/tenofovir disoproxil fumarate

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

Efavirenz

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

Nevirapine

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

Trimethoprim/sulfamethoxazole

DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004

Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010

AMPATH at Moi Univ. Teaching Hosp. Eldoret CRS (12601)

Walter Reed Project - Kenya Med. Research Institute Kericho CRS (12501)

Kisumu Crs (31460)

College of Med. JHU CRS (30301)

Joint Clinical Research Centre (JCRC) (12401)

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

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

AIDS Clinical Trials Group

National Institute of Allergy and Infectious Diseases (NIAID)

Biological/Vaccine: 189 volunteers will receive the Malaria vaccine MSP3 Long Synthetic Peptide (LSP)
Arms: MSP3 LSP vaccine Biological/Vaccine:MSP3 LSP 30 micrograms of MSP3 LSP
Arms: I, MSP3 LSP vaccine

189 volunteers will receive standard vaccine against rabies on the similar schedule on days 0, 28, and 56

Malaria

189 children will receive 3 doses of experimental vaccine

MSP3 Long Synthetic Peptide 30 micrograms of MSP3 LSP

189 volunteers will receive Verorab vaccine, 0.5 Ml at day 0, 28 and 56.

Verorab vaccine

Malaria Research Training Center

Immunogenicity, Efficacy and Safety Study of an MSP3-LSP (Long Synthetic Peptide) Malaria Vaccine

Phase IIb Immunogenicity, Efficacy and Safety Study of P. Falciparum Vaccine Candidate, MSP3-LSP Adjuvanted in Aluminium Hydroxide Versus Verorab Control in Healthy Children Aged 12-48 Months in Mali.

parasitemia/phosphatase

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

Immunogenicity, Efficacy and Safety Study of an MSP3-LSP (Long Synthetic Peptide) Malaria Vaccine

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