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

University of Ibadan

Status and phase: Completed; Phase 1

Conditions: HIV; Malaria; Pregnant

Treatments: Drug: Sulphadoxine-pyrimethamine; Drug: Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02527005

UIbadan

Details and patient eligibility

About

Randomized controlled single blind prospective comparative study

Full 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

Enrollment: 140 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Azithromycin

Active Comparator group

Description:

Tabs Azithromycin 500mg daily for 3 days

Treatment:

Drug: Azithromycin

Drug: Sulphadoxine-pyrimethamine

Sulphadoxine-pyrimethamine

Active Comparator group

Description:

500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets every 4 weeks for 3 doses

Treatment:

Drug: Azithromycin

Drug: Sulphadoxine-pyrimethamine