MalariaPhase 1NCT02527005
A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients
A Phase 1 study testing Sulphadoxine-pyrimethamine and Azithromycin in people with Malaria and Pregnant, run by University of Ibadan at 1 site in Nigeria.
Trial summary
Randomized controlled single blind prospective comparative study Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- What is being tested?
- Sulphadoxine-pyrimethamine and Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteNigeria
- Study dates
- Sep 2015to Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant HIV positive patients,
- Gestational age 16 weeks and above,
- No history of azithromycin or sulphadoxine-pyrimethamine use four weeks prior to recruitment
Who cannot join
- Anaemia packed cell volume less than 30%,
- pre-existing medical conditions- diabetes mellitus,
- hypertension,
- allergy to sulphadoxine-pyrimethamine or azithromycin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Azithromycin and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant HIV Positive Patients
Randomized controlled single blind prospective comparative study
Read the 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
- Being tested
- Sulphadoxine-pyrimethamine, Azithromycin
- Keywords
- IPT, malaria, pregnant, HIV positive
- Medical subject headings
- Malaria, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulphadoxine-pyrimethamineDrug
Also called Vitadar
Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly for 3 doses
AzithromycinDrug
Also called Zithromax
Tabs Azithromycin 500mg daily for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin | Active comparator | Tabs Azithromycin 500mg daily for 3 days Receives: Drug: Sulphadoxine-pyrimethamine; Drug: Azithromycin |
| Sulphadoxine-pyrimethamine | Active comparator | 500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets every 4 weeks for 3 doses Receives: Drug: Sulphadoxine-pyrimethamine; Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ibadan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ORIYOMI OMOTOYOSI AKINYOTU, University of Ibadan
- Investigators
- AYODELE O AROWOJOLU, MBBS IBADAN, Study director, UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE, NIGERIAORIYOMI O AKINYOTU, MBBS IBADAN, Principal investigator, UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIAADENIKE F BELLO, MBBS IBADAN, Study director, UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIAADEOLA R ABDUS-SALAM, MBBS IBADAN, Study director, ADEOYO MATERNITY TEACHING HOSPITAL, IBADAN, OYO STATE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527005
- Sponsor's protocol ID
- UIbadan
- Status last verified
- Dec 2017
- First submitted
- 14 Aug 2015
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10028075Pons-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.
PubMed 39324693
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Azithromycin and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant HIV Positive Patients
- ClinicalTrials.gov ID
- NCT02527005
- Acronym / sponsor ID
- UIbadan
- Keywords
- IPT, malaria, pregnant, HIV positive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of IbadanUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | Active comparator | Drug: Sulphadoxine-pyrimethamine, Drug: AzithromycinTabs Azithromycin 500mg daily for 3 days |
| Sulphadoxine-pyrimethamine | Active comparator | Drug: Sulphadoxine-pyrimethamine, Drug: Azithromycin500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets every 4 weeks for 3 doses |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant HIV positive patients,
- Gestational age 16 weeks and above,
- No history of azithromycin or sulphadoxine-pyrimethamine use four weeks prior to recruitment
Key exclusion criteria (4 listed)
- Anaemia packed cell volume less than 30%,
- pre-existing medical conditions- diabetes mellitus,
- hypertension,
- allergy to sulphadoxine-pyrimethamine or azithromycin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulphadoxine-pyrimethamineAlso: VitadarSulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly for 3 doses | Drug | Azithromycin, Sulphadoxine-pyrimethamine |
| AzithromycinAlso: ZithromaxTabs Azithromycin 500mg daily for 3 days | Drug | Azithromycin, Sulphadoxine-pyrimethamine |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
- Background: PubMed 10028075Taylor 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.
- Derived from this study: PubMed 39324693Pons-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AYODELE O AROWOJOLU, MBBS IBADAN study director
UNIVERSITY COLLEGE HOSPITAL,IBADAN,OYO STATE, NIGERIA
ORIYOMI O AKINYOTU, MBBS IBADAN principal investigator
UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIA
ADENIKE F BELLO, MBBS IBADAN study director
UNIVERSITY COLLEGE HOSPITAL, IBADAN, OYO STATE, NIGERIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sulphadoxine-pyrimethamine and Azithromycin in people with Malaria and Pregnant, run by University of Ibadan at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02527005, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.