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

NCT ID: NCT02527005

Last Updated: 2017-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-08-31

Brief Summary

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Randomized controlled single blind prospective comparative study

Detailed Description

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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

Conditions

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Malaria Pregnant HIV

Keywords

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IPT malaria pregnant HIV positive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Azithromycin

Tabs Azithromycin 500mg daily for 3 days

Group Type ACTIVE_COMPARATOR

Sulphadoxine-pyrimethamine

Intervention Type DRUG

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

Azithromycin

Intervention Type DRUG

Tabs Azithromycin 500mg daily for 3 days

Sulphadoxine-pyrimethamine

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

Group Type ACTIVE_COMPARATOR

Sulphadoxine-pyrimethamine

Intervention Type DRUG

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

Azithromycin

Intervention Type DRUG

Tabs Azithromycin 500mg daily for 3 days

Interventions

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Sulphadoxine-pyrimethamine

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

Intervention Type DRUG

Azithromycin

Tabs Azithromycin 500mg daily for 3 days

Intervention Type DRUG

Other Intervention Names

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Vitadar Zithromax

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ibadan

OTHER

Sponsor Role lead

Responsible Party

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ORIYOMI OMOTOYOSI AKINYOTU

Senior Registrar

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AYODELE O AROWOJOLU, MBBS IBADAN

Role: STUDY_DIRECTOR

UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE, NIGERIA

ORIYOMI O AKINYOTU, MBBS IBADAN

Role: PRINCIPAL_INVESTIGATOR

UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIA

ADENIKE F BELLO, MBBS IBADAN

Role: STUDY_DIRECTOR

UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIA

ADEOLA R ABDUS-SALAM, MBBS IBADAN

Role: STUDY_DIRECTOR

ADEOYO MATERNITY TEACHING HOSPITAL, IBADAN, OYO STATE

Locations

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University College Hospital,

Ibadan, Oyo State, Nigeria

Site Status

Countries

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Nigeria

References

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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.

Reference Type BACKGROUND
PMID: 10028075 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39324693 (View on PubMed)

Other Identifiers

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UIbadan

Identifier Type: -

Identifier Source: org_study_id