Malaria in Pregnant HIV + PatientsPhase 1NCT02524444
A Comparative Study of Mefloquine and S-P as Prophylaxis Against Malaria in Pregnant HIV + Patients
A Phase 1 study testing Mefloquine and Sulphadoxine-Pyrimethamine in people with Malaria in Pregnant HIV + Patients, run by ORIYOMI OMOTOYOSI AKINYOTU 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
- Conditions the study is for
- Malaria in Pregnant HIV + Patients
- What is being tested?
- Mefloquine and Sulphadoxine-Pyrimethamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 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 use of Mefloquine or Sulphadoxine
- Pyrimethamine 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 Mefloquine
- Non-consenting patients
- Multiple gestation
- Known psychiatric illness
- Known seizure disorder
- History of severe renal or hepatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Mefloquine and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant Human Immunodeficiency Virus 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 with Mefloquine as-intermittent preventive therapy in HIV-infected pregnant women.
- Conditions
- Malaria in Pregnant HIV + Patients
- Being tested
- Mefloquine, Sulphadoxine-Pyrimethamine
- Keywords
- Intermittent preventive therapy, malaria, pregnant, HIV positive, Prevention
- 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.
MefloquineDrug
Also called Larimef
Tabs Mefloquine 250mg
Sulphadoxine-PyrimethamineDrug
Also called Vitadar, Fansidar
Sulphadoxine 500mg , Pyrimethamine 25mg
| Study group | Role | What they receive |
|---|---|---|
| Mefloquine | Active comparator | Tabs Mefloquine 250mg 3 doses 4 weeks apart Receives: Drug: Mefloquine |
| Sulphadoxine-Pyrimethamine | Active comparator | 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets 4 weeks apart for 3 doses Receives: Drug: Sulphadoxine-Pyrimethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of malaria parasitemia in HIV positive women at delivery after administration of Mefloquine or sulphadoxine-pyrimethamine as prophylaxis 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 posted14 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 (3)Papers the sponsor has linked to this study.
- Other trials for Malaria in Pregnant HIV + PatientsStudies 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
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- ORIYOMI OMOTOYOSI AKINYOTU
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ibadan
- Responsible party
- Sponsor-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, NIGERIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524444
- Sponsor's protocol ID
- FDAAA
- Status last verified
- Dec 2017
- First submitted
- 5 Aug 2015
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Steketee RW, Wirima JJ, Slutsker L, Khoromana CO, Heymann DL, Breman JG. Malaria treatment and prevention in pregnancy: indications for use and adverse events associated with use of chloroquine or mefloquine. Am J Trop Med Hyg. 1996;55(1 Suppl):50-6. doi: 10.4269/ajtmh.1996.55.50.
PubMed 8702037Pons-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 39324693Akinyotu O, Bello F, Abdus-Salam R, Arowojolu A. Comparative study of mefloquine and sulphadoxine-pyrimethamine for malaria prevention among pregnant women with HIV in southwest Nigeria. Int J Gynaecol Obstet. 2018 Aug;142(2):194-200. doi: 10.1002/ijgo.12516. Epub 2018 May 25.
PubMed 29719927
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 Mefloquine and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant Human Immunodeficiency Virus Positive Patients
- ClinicalTrials.gov ID
- NCT02524444
- Acronym / sponsor ID
- FDAAA
- Conditions
- Malaria in Pregnant HIV + Patients
- Keywords
- Intermittent preventive therapy, malaria, pregnant, HIV positive, Prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- ORIYOMI OMOTOYOSI AKINYOTUUniversity, hospital or other
- Collaborators
- University of Ibadan
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 14 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 with Mefloquine as-intermittent preventive therapy in HIV-infected 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 |
|---|---|---|
| Mefloquine | Active comparator | Drug: MefloquineTabs Mefloquine 250mg 3 doses 4 weeks apart |
| Sulphadoxine-Pyrimethamine | Active comparator | Drug: Sulphadoxine-Pyrimethamine500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets 4 weeks apart for 3 doses |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant HIV positive patients
- Gestational age 16 weeks and above
- No history of use of Mefloquine or Sulphadoxine
- Pyrimethamine four weeks prior to recruitment.
Key exclusion criteria (8 listed)
- Anaemia packed cell volume less than 30%
- Pre -existing medical conditions- Diabetes Mellitus, -Hypertension
- Allergy to Sulphadoxine- Pyrimethamine or Mefloquine
- Non-consenting patients
- Multiple gestation
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 |
|---|---|---|
| MefloquineAlso: LarimefTabs Mefloquine 250mg | Drug | Mefloquine |
| Sulphadoxine-PyrimethamineAlso: Vitadar, FansidarSulphadoxine 500mg , Pyrimethamine 25mg | Drug | Sulphadoxine-Pyrimethamine |
Primary outcome
Level of malaria parasitemia in HIV positive women at delivery after administration of Mefloquine or sulphadoxine-pyrimethamine as prophylaxis 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 8702037Steketee RW, Wirima JJ, Slutsker L, Khoromana CO, Heymann DL, Breman JG. Malaria treatment and prevention in pregnancy: indications for use and adverse events associated with use of chloroquine or mefloquine. Am J Trop Med Hyg. 1996;55(1 Suppl):50-6. doi: 10.4269/ajtmh.1996.55.50.
- 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.
- Derived from this study: PubMed 29719927Akinyotu O, Bello F, Abdus-Salam R, Arowojolu A. Comparative study of mefloquine and sulphadoxine-pyrimethamine for malaria prevention among pregnant women with HIV in southwest Nigeria. Int J Gynaecol Obstet. 2018 Aug;142(2):194-200. doi: 10.1002/ijgo.12516. Epub 2018 May 25.
- Individual participant dataSharing planned: Undecided
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 Mefloquine and Sulphadoxine-Pyrimethamine in people with Malaria in Pregnant HIV + Patients, run by ORIYOMI OMOTOYOSI AKINYOTU 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 4 inclusion and 8 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 in HIV positive women at delivery after administration of Mefloquine or sulphadoxine-pyrimethamine as prophylaxis 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 NCT02524444, which also lists 3 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; AzTrials last refreshed its copy on 6 Nov 2026.