Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and … (NCT03227731) | Clinical Trial Compass
CompletedPhase 2/3
Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women
South Africa540 participantsStarted 2017-09-28
Plain-language summary
An Open Label randomized control study. To explore the safety of Truvada when used as PrEP during pregnancy and lactation. Pregnant women considered at risk for HIV infection and willing to participate in this randomized control study will be randomized to commencing PrEP in pregnancy and continued use throughout breastfeeding or deferred PrEP until breastfeeding cessation. All women will receive the standard of care for prevention of HIV and other sexually transmitted infections.
Arm A: (Intervention): Standard HIV Prevention strategy plus a once daily dose of Truvada (FTC 200mg/TDF 300mg tablet) initiated in pregnancy, continuing until cessation of breastfeeding or 18 months postdelivery whichever is earliest and thereafter the option to continue PrEP post breastfeeding cessation.
Arm B: (Control): Standard HIV Prevention strategy throughout pregnancy until cessation of breastfeeding plus the offer to initiate PrEP post breastfeeding cessation.
Standard HIV prevention strategy includes risk reduction counselling, sexually transmitted infection (STI) screening and treatment, condom promotion and inviting the sexual partner to receive HIV counselling and testing (HCT) and referral for antiretroviral therapy (ART) if he tests positive.
Main Outcome Measure: Renal function, pregnancy outcomes, bone health and infant growth.
Other Outcome Measure: Incident HIV infections, adherence to PrEP, drug resistance and mother-to-child transmission of HIV.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least 18 years old.
* Confirmed HIV-1 uninfected.
* Willing to provide screening informed consent
* Currently pregnant
* Considered high risk for HIV infection
* Unprotected sex during pregnancy
* HIV status of current sexual partner is positive or unknown
* Results of Hepatitis B Virus (HBV) screening (HBsAg testing) available from specimen obtained within 30 days prior to entry
* Plans to deliver in the study affiliated hospital
* Has no plans to move residence outside of the catchment area during the 18 months following delivery
Exclusion Criteria:
* HIV infected
* \<18 years of age
* The following laboratory values from a specimen obtained within 30 days prior to study entry:
* Hemoglobin \<9.5 g/dL
* White Blood Cell Count (WBC) \< 1500 cells/mm3
* Absolute Neutrophil Count (ANC) \< 750 cells/mm3
* Platelets \< 100,000 cells/mm3
* Alanine Aminotransferase (ALT) \> 2.5 x upper limit of normal (ULN)
* Estimated creatinine clearance of \< 70 ml/min using the cockcroft-gault equation for women: {(\[140 - age (years)\] x \[weight (kg)\]) ÷ \[72 x serum Cr (mg/dL)\]} x 0.85
* Hepatitis B surface antigen (HBsAg) positive
* Participation in any other study
* In labour - at onset or beyond
* Serious illness (including TB) and/or hospitalization
* Receipt of TB treatment within 30 days prior to study entry
* Fetus detected with serious congenital malformation (ultrasound not required to rule out this condition)
* History of documente…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pregnancy Outcome-Preterm Deliveries
Timeframe: Within 72 hours postdelivery
2
Bone Mineral Density in mother and infant
Timeframe: 6 weeks postdelivery, and thereafter 6 monthly until week 74