Influence of Chloroquine on HIV Viral Load Among Pregnant Women in Uganda
Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
N/A
Details
Lead Sponsor:
Gates Malaria Partnership London School of Hygiene and Tropical Medicine
Collaborators:
DBL -Institute for Health Research and Development Uganda AIDS Commission
Treatments:
Chloroquine Chloroquine diphosphate Fanasil, pyrimethamine drug combination Pyrimethamine Sulfadoxine