Improving PRegnancy Outcomes With PReVEntive Therapy in Africa-2 (IMPROVE-2)
Phase 3
Recruiting
- Conditions
- Malaria
- Registration Number
- PACTR202005916875055
- Lead Sponsor
- iverpool School of Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 898
Inclusion Criteria
HIV-infected pregnant women between 16-28 weeks' gestation
Viable singleton pregnancy
On or eligible for cARTs and CTX
A resident of the study area
Willing to adhere to scheduled and unscheduled study visit procedures
Willing to deliver in a study clinic or hospital
Provide written informed consen
Exclusion Criteria
Multiple pregnancies (i.e. twin/triplets)
HIV-negative or HIV status unknown
Known heart ailment
Severe malformations or non-viable pregnancy if observed by ultrasound
Participants with advanced HIV-disease at WHO clinical stage 3 and 4
Confirmed or suspected TB infection,
Unable to give consent
Known allergy or contraindication to any of the study drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method