Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women (PrEP)
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|ClinicalTrials.gov Identifier: NCT03227731|
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : March 29, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV-1-infection||Drug: Truvada||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||842 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Pregnant women considered at high risk for HIV infection will be randomized to commencing PrEP in pregnancy with continued use throughout breastfeeding or deferred PrEP until breastfeeding cessation. Women in either group will receive the standard of care for prevention of HIV and other sexually transmitted infections.|
|Masking:||None (Open Label)|
|Official Title:||Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women An Open-Label Randomised Control Study|
|Actual Study Start Date :||September 28, 2017|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||May 30, 2022|
Active Comparator: Arm A (Intervention - Truvada)
Standard HIV Prevention strategy plus a once daily dose of Truvada (FTC 200mg/TDF 300mg tablet) initiated in pregnancy and continuing until cessation of breastfeeding or 18 months postdelivery whichever is earliest and thereafter the option to continue PrEP post breastfeeding cessation.
Truvada (Truvada (emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) is in a fixed-dose combination (FDC) tablet formulation and is proven safe for the prevention and treatment of HIV in non-pregnant and non-lactating women.
Other Name: emtricitabine 200mg/tenofovir disoproxil fumarate 300mg)
No Intervention: Arm B (Control - Standard of Care)
Standard HIV Prevention strategy throughout pregnancy until 18 months postdelivery plus the offer to initiate PrEP post breastfeeding cessation
- Pregnancy Outcome-Preterm Deliveries [ Time Frame: Within 72 hours postdelivery ]Number of preterm deliveries < 37 weeks gestation
- Bone Mineral Density in mother and infant [ Time Frame: 6 weeks postdelivery, and thereafter 6 monthly until week 74 ]Number of participants with decreased bone mineral density of hip and spine
- Pregnancy Outcome-Low Birth Weight [ Time Frame: Within 72 hours ]Number of Low birth weight babies <2500g
- Incident HIV infection [ Time Frame: Monthly during pregnancy and until 74 weeks postdelivery ]Number of Incident HIV infections in women
- Adherence to PrEP [ Time Frame: Monthly during pregnancy and until 74 weeks postdelivery ]Number of women with >90% adherence to PrEP
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227731
|Contact: Dhayendre Moodley, PhD||+27(0)firstname.lastname@example.org|
|Contact: Vani Govender, BTechHons||+27(0)email@example.com|
|University of KwaZulu-Natal||Recruiting|
|Durban, KwaZulu-Natal, South Africa, 4001|
|Contact: Karen Reinertsen +27(0)312608850 firstname.lastname@example.org|
|Principal Investigator:||Dhayendre Moodley, PhD||University of KwaZulu|