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

Phase 1

Completed

• Conditions: Pregnant; HIV; Malaria
• Interventions: Drug: Sulphadoxine-pyrimethamine; Drug: Azithromycin

• Registration Number: NCT02527005
• Lead Sponsor: University of Ibadan

Brief Summary

Randomized controlled single blind prospective comparative study

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 for malaria with azithromycin in HIV positive pregnant women

Study Timeline

• Study First Submitted: 2015-08-14
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-18
• Study Start: 2015-09
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-07
• Last Update Posted: 2017-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azithromycin	Sulphadoxine-pyrimethamine	Tabs Azithromycin 500mg daily for 3 days
Sulphadoxine-pyrimethamine	Sulphadoxine-pyrimethamine	500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets every 4 weeks for 3 doses
Azithromycin	Azithromycin	Tabs Azithromycin 500mg daily for 3 days
Sulphadoxine-pyrimethamine	Azithromycin	500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets every 4 weeks for 3 doses

Primary Outcome Measures

Name	Time	Method
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	6 months

Trial Locations

Locations (1)

University College Hospital,; 🇳🇬 Ibadan, Oyo, Nigeria