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

A Comparative Study of Azithromycin and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant HIV Positive Patients

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02527005

Enrollment

140

Registered

2015-08-18

Start date

2015-09-30

Completion date

2016-08-31

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria, Pregnant, HIV

Keywords

IPT, malaria, pregnant, HIV positive

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

Interventions

DRUGSulphadoxine-pyrimethamine

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

DRUGAzithromycin

Tabs Azithromycin 500mg daily for 3 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Nigeria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026