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Influence of Chloroquine on HIV Viral Load Among Pregnant Women in Uganda
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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 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 |
- 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 (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00132535
| Uganda | |
| Uganda AIDS Commission | |
| Kampala, Uganda, P.O. Box 10779 | |
| Principal Investigator: | Lucy N Korukiiko, MPH | Uganda AIDS Commission |
More Information
Additional Information:
| 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 |
| Study First Received: | August 19, 2005 |
| Last Updated: | January 11, 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 |
ClinicalTrials.gov processed this record on July 25, 2017