Influence of Chloroquine on HIV Viral Load Among Pregnant Women in Uganda
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|ClinicalTrials.gov Identifier: NCT00132535|
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : January 12, 2017
There is conflicting evidence regarding the influence of HIV infection on the success of malaria prevention in pregnancy and effect on pregnancy outcome. The purpose of the proposed study is to assess the impact of HIV infection on the effectiveness of malaria prevention during pregnancy. This will be carried out by comparing two intermittent preventive treatments (IPTs) with sulfadoxine/pyrimethamine (SP) plus 300 mg weekly chloroquine with two doses IPT plus a weekly chloroquine placebo. The emphasis will be on assessing the effect of chloroquine on HIV viral load and malaria morbidity and foetal outcome.
The study will be a randomised double-blind placebo-controlled trial with two arms, involving pregnant women attending antenatal classes (ANCs) at health units, enrolled early in their second trimester at 3 health units of the Mbarara district and Kampala. All pregnant women presenting for antenatal care, irrespective of parity, who consent to participate will be enrolled. Women with severe systemic disease or symptoms of AIDS will be excluded from the study data analysis.
Women will be screened for HIV status and their HIV viral loads will be measured at enrolment. Parasitaemia will be assessed at enrolment; at the beginning of the third trimester; and at delivery. Haemoglobin will be measured at the same time points.
The main outcome variables to be assessed will be maternal peripheral parasitaemia; placental parasitaemia; maternal clinical malaria; congenital parasitaemia; and maternal and neonatal haemoglobin, birth weight and viral load at enrolment and before nevirapine administration to the HIV positive mothers at birth.
Anthropological pre-studies to assess the quality of ANC services and healthcare seeking practices of pregnant women in the study area will be carried out. Focus group discussions (FGD) with pregnant women and mothers of neonates; in-depth interviews with relevant health workers; and illness narratives from pregnant women will be used to collect data. The anthropological study results will assist in appropriately planning for the trial to enhance compliance to the intervention.
The data collection is planned to commence in August 2003 and is expected to end in October 2005. Twelve months will be spent on the write-up phase.
|Condition or disease||Intervention/treatment||Phase|
|Malaria in Pregnancy HIV Infections||Drug: sulfadoxine-pyrimethamine intermittent preventive treatment Drug: chloroquine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||2548 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Influence of HIV Infection on the Effectiveness of Malaria Prevention During Pregnancy, With Emphasis on the Effect of Chloroquine on HIV Viral Load Among Pregnant Women in Uganda|
|Study Start Date :||August 2003|
|Actual Study Completion Date :||June 2007|
- maternal peripheral parasitaemia
- placental parasitaemia
- clinical malaria
- maternal and infant Hb
- birth weight
- congenital parasitaemia
- maternal HIV viral load at inclusion and before delivery
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132535
|Uganda AIDS Commission|
|Kampala, Uganda, P.O. Box 10779|
|Principal Investigator:||Lucy N Korukiiko, MPH||Uganda AIDS Commission|