NCT02527005

Brief Summary

Randomized controlled single blind prospective comparative study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

December 11, 2017

Status Verified

December 1, 2017

Enrollment Period

11 months

First QC Date

August 14, 2015

Last Update Submit

December 7, 2017

Conditions

MalariaPregnantHIV

Keywords

IPTmalariapregnantHIV positive

Outcome Measures

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

    6 months

Study Arms (2)

Azithromycin

ACTIVE COMPARATOR

Tabs Azithromycin 500mg daily for 3 days

Drug: Sulphadoxine-pyrimethamineDrug: Azithromycin

Sulphadoxine-pyrimethamine

ACTIVE COMPARATOR

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

Drug: Sulphadoxine-pyrimethamineDrug: Azithromycin

Interventions

Sulphadoxine-pyrimethamineDRUG

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

Also known as: Vitadar
AzithromycinSulphadoxine-pyrimethamine
AzithromycinDRUG

Tabs Azithromycin 500mg daily for 3 days

Also known as: Zithromax
AzithromycinSulphadoxine-pyrimethamine

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant HIV positive patients,
  • Gestational age 16 weeks and above,
  • No history of azithromycin or sulphadoxine-pyrimethamine use four weeks prior to recruitment

You may not qualify if:

  • Anaemia packed cell volume less than 30%,
  • pre-existing medical conditions- diabetes mellitus,
  • hypertension,
  • allergy to sulphadoxine-pyrimethamine or azithromycin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Hospital,

Ibadan, Oyo State, 200001, Nigeria

Location

Related Publications (2)

  • 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. doi: 10.1086/515071.

    PMID: 10028075BACKGROUND

  • Pons-Duran C, Wassenaar MJ, Yovo KE, Marin-Carballo C, Briand V, Gonzalez R. Intermittent preventive treatment regimens for malaria in HIV-positive pregnant women. Cochrane Database Syst Rev. 2024 Sep 26;9(9):CD006689. doi: 10.1002/14651858.CD006689.pub3.

    PMID: 39324693DERIVED

MeSH Terms

Conditions

MalariaHIV Seropositivity

Interventions

fanasil, pyrimethamine drug combinationAzithromycin

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • AYODELE O AROWOJOLU, MBBS IBADAN

    UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE, NIGERIA

    STUDY DIRECTOR

  • ORIYOMI O AKINYOTU, MBBS IBADAN

    UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIA

    PRINCIPAL INVESTIGATOR

  • ADENIKE F BELLO, MBBS IBADAN

    UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIA

    STUDY DIRECTOR

  • ADEOLA R ABDUS-SALAM, MBBS IBADAN

    ADEOYO MATERNITY TEACHING HOSPITAL, IBADAN, OYO STATE

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Registrar

Study Record Dates

First Submitted

August 14, 2015

First Posted

August 18, 2015

Study Start

September 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

December 11, 2017

Record last verified: 2017-12

Locations

NG(1)