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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527005
• Other study ID #: UIbadan
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2015
• Last updated: December 7, 2017
• Start date: September 2015
• Est. completion date: August 2016

Study information

• Verified date: December 2017
• Source: University of Ibadan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized controlled single blind prospective comparative study

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Malaria
• Pregnant

Intervention

Drug:
• Sulphadoxine-pyrimethamine
Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly for 3 doses
• Azithromycin
Tabs Azithromycin 500mg daily for 3 days

Locations

Country	Name	City	State
Nigeria	University College Hospital,	Ibadan	Oyo

Sponsors (1)

Lead Sponsor	Collaborator
University of Ibadan

Country where clinical trial is conducted

Nigeria, 

References & Publications (1)

Taylor WR, Richie TL, Fryauff DJ, Picarima H, Ohrt C, Tang D, Braitman D, Murphy GS, Widjaja H, Tjitra E, Ganjar A, Jones TR, Basri H, Berman J. Malaria prophylaxis using azithromycin: a double-blind, placebo-controlled trial in Irian Jaya, Indonesia. Clin Infect Dis. 1999 Jan;28(1):74-81. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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