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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
Sponsor:
Collaborators:
DBL -Institute for Health Research and Development
Uganda AIDS Commission
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Malaria in Pregnancy HIV Infections Drug: sulfadoxine-pyrimethamine intermittent preventive treatment Drug: chloroquine Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 2548 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
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
Study Start Date : August 2003
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Malaria
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. maternal peripheral parasitaemia
  2. placental parasitaemia
  3. clinical malaria
  4. maternal and infant Hb
  5. birth weight
  6. congenital parasitaemia
  7. maternal HIV viral load at inclusion and before delivery

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132535


Locations
Uganda
Uganda AIDS Commission
Kampala, Uganda, P.O. Box 10779
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
DBL -Institute for Health Research and Development
Uganda AIDS Commission
Investigators
Principal Investigator: Lucy N Korukiiko, MPH Uganda AIDS Commission
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
DBL-Centre for Health Research and Development  This link exits the ClinicalTrials.gov site

Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00132535     History of Changes
Other Study ID Numbers: MV-714-624-03-0001
First Posted: August 22, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:
Malaria in pregnancy
IPT
Sulphadoxine-pyrimethamine
Chloroquine
 HIV
Viral load
birth weight
anaemia

Additional relevant MeSH terms:
Infection
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
Fanasil, pyrimethamine drug combination
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents