Skip to main content
OpenTrials
Completed

NCT Number: NCT02527005

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

Randomized controlled single blind prospective comparative study

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malaria Blood-Borne Infections Communicable Diseases Genital Diseases HIV HIV Infections HIV Seropositivity Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mosquito-Borne Diseases Parasitic Diseases Pregnant Protozoan Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Vector Borne Diseases Virus Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University College Hospital,

Ibadan, Oyo State, 200001, Nigeria

About this 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulphadoxine-pyrimethamine

Drug

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

Other names: Vitadar

Azithromycin

Drug

Tabs Azithromycin 500mg daily for 3 days

Other names: Zithromax

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Ibadan

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 18, 2015
Registry last updated
Dec 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.