A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients

University of Ibadan140 enrolled

Overview

Randomized controlled single blind prospective comparative study

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 for malaria with azithromycin in HIV positive pregnant women

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

140

Conditions

Malaria Pregnant HIV

Interventions

Sulphadoxine-pyrimethamineDRUG

Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly for 3 doses

AzithromycinDRUG

Tabs Azithromycin 500mg daily for 3 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant HIV positive patients, * Gestational age 16 weeks and above, * No history of azithromycin or sulphadoxine-pyrimethamine use 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 azithromycin

Locations (1)

University College Hospital,

Ibadan, Oyo State, Nigeria

Outcomes

Primary Outcomes

Level of malaria parasitemia at delivery in HIV positive women following administration of Azithromycin or Sulphadoxine- pyrimethamine as intermittent preventive therapy for malaria in pregnancy

Time frame: 6 months

Data from ClinicalTrials.gov

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