Influence of Chloroquine on HIV Viral Load Among Pregnant Women in Uganda

This study has been completed.
Sponsor:
Collaborators:
DBL -Institute for Health Research and Development
Uganda AIDS Commission
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00132535
First received: August 19, 2005
Last updated: January 14, 2009
Last verified: January 2009
  Purpose

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 Intervention
Malaria in Pregnancy
HIV Infections
Drug: sulfadoxine-pyrimethamine intermittent preventive treatment
Drug: chloroquine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • maternal peripheral parasitaemia
  • placental parasitaemia
  • clinical malaria
  • maternal and infant Hb
  • birth weight
  • congenital parasitaemia
  • maternal HIV viral load at inclusion and before delivery

Estimated Enrollment: 2548
Study Start Date: August 2003
Study Completion Date: June 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women
  • 14-24 weeks gestation
  • Consent
  • Presenting for ANC at study hospitals/centres
  • Agree to have an HIV test and to be examined for viral load

Exclusion Criteria:

  • Severe systemic disease
  • AIDS-related disease
  • At-risk pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00132535

Locations
Uganda
Uganda AIDS Commission
Kampala, Uganda, P.O. Box 10779
Sponsors and Collaborators
Gates Malaria Partnership
DBL -Institute for Health Research and Development
Uganda AIDS Commission
Investigators
Principal Investigator: Lucy N Korukiiko, MPH Uganda AIDS Commission
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00132535     History of Changes
Other Study ID Numbers: MV-714-624-03-0001
Study First Received: August 19, 2005
Last Updated: January 14, 2009
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Gates Malaria Partnership:
Malaria in pregnancy
IPT
Sulphadoxine-pyrimethamine
Chloroquine
HIV
Viral load
birth weight
anaemia

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Malaria
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protozoan Infections
Parasitic Diseases
Chloroquine
Chloroquine diphosphate
Pyrimethamine
Sulfadoxine
Sulfadoxine-pyrimethamine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

ClinicalTrials.gov processed this record on April 23, 2014