A Comparative Study of Mefloquine and S-P as Prophylaxis Against Malaria in Pregnant HIV + Patients
Information source: University of Ibadan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria in Pregnant HIV + Patients
Intervention: Mefloquine (Drug); Sulphadoxine-Pyrimethamine (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: ORIYOMI OMOTOYOSI AKINYOTU Official(s) and/or principal investigator(s):
AYODELE O AROWOJOLU, MBBS IBADAN, Study Director, Affiliation: UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE, NIGERIA
ORIYOMI O AKINYOTU, MBBS IBADAN, Principal Investigator, Affiliation: UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE,NIGERIA
ADENIKE F BELLO, MBBS IBADAN, Study Director, Affiliation: UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE, NIGERIA
Overall contact:
ORIYOMI O AKINYOTU, MBBS IBADAN, Phone: +2348035044590, Email: oriyomiddoc@yahoo.com
Summary
Randomized controlled single blind prospective comparative study.
Clinical Details
Official title: A Comparative Study of Mefloquine and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant Human Immunodeficiency Virus Positive Patients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Level of malaria parasitemia in HIV positive women at delivery after administration of Mefloquine or sulphadoxine-pyrimethamine as prophylaxis for malaria in pregnancy
Detailed description:
This study is intended to be a randomized controlled single blind prospective comparative
study conducted to compare the efficacy of three, monthly doses of
sulphadoxine-pyrimethamine as intermittent preventive therapy with Mefloquine
as-intermittent preventive therapy in HIV-infected pregnant women.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Pregnant HIV positive patients
- Gestational age 16 weeks and above
- No history of use of Mefloquine or Sulphadoxine
- Pyrimethamine four weeks prior to recruitment.
Exclusion Criteria:
- Anaemia packed cell volume less than 30%
- Pre -existing medical conditions- Diabetes Mellitus, -Hypertension
- Allergy to Sulphadoxine- Pyrimethamine or Mefloquine
- Non-consenting patients
- Multiple gestation
- Known psychiatric illness
- Known seizure disorder
- History of severe renal or hepatic disease
Locations and Contacts
ORIYOMI O AKINYOTU, MBBS IBADAN, Phone: +2348035044590, Email: oriyomiddoc@yahoo.com
University College Hospital, Ibadan, Oyo State 200001, Nigeria; Not yet recruiting
ORIYOMI O AKINYOTU, MBBS IBADAN, Phone: +2348035044590, Email: oriyomiddoc@yahoo.com
ADENIKE F BELLO, MBBS IBADAN, Phone: +2348037084505, Email: nikeoluyemi@yahoo.com
ORIYOMI O AKINYOTU, MBBS IBADAN, Principal Investigator
Additional Information
Related publications: Steketee RW, Wirima JJ, Slutsker L, Khoromana CO, Heymann DL, Breman JG. Malaria treatment and prevention in pregnancy: indications for use and adverse events associated with use of chloroquine or mefloquine. Am J Trop Med Hyg. 1996;55(1 Suppl):50-6.
Starting date: September 2015
Last updated: August 12, 2015
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