NCT00132535

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,548

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

First QC Date

August 19, 2005

Last Update Submit

January 11, 2017

Conditions

Malaria in PregnancyHIV Infections

Keywords

Malaria in pregnancyIPTSulphadoxine-pyrimethamineChloroquineHIVViral loadbirth weightanaemia

Outcome Measures

Primary Outcomes (7)

  • maternal peripheral parasitaemia

  • placental parasitaemia

  • clinical malaria

  • maternal and infant Hb

  • birth weight

  • congenital parasitaemia

  • maternal HIV viral load at inclusion and before delivery

Interventions

sulfadoxine-pyrimethamine intermittent preventive treatmentDRUG
chloroquineDRUG

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pregnant women
  • weeks gestation
  • Consent
  • Presenting for ANC at study hospitals/centres
  • Agree to have an HIV test and to be examined for viral load

You may not qualify if:

  • Severe systemic disease
  • AIDS-related disease
  • At-risk pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uganda AIDS Commission

Kampala, Kampala, P.O. Box 10779, Uganda

Location

Related Publications (1)

  • Pons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3.

    PMID: 39324693DERIVED

Related Links

MeSH Terms

Conditions

HIV InfectionsBirth WeightAnemia

Interventions

Chloroquine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Lucy N Korukiiko, MPH

    Uganda AIDS Commission

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 19, 2005

First Posted

August 22, 2005

Study Start

August 1, 2003

Study Completion

June 1, 2007

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

UG(1)