Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women

• Status: Active, not recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of KwaZulu
• Collaborators: Centre for the AIDS Programme of Research in South Africa; Medical Research Council, South Africa
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

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 documented structural or conduction heart defect

• Social or other circumstances which would hinder long-term follow-up, in the opinion of the site investigator

• Currently incarcerated

• Substance or alcohol abuse (a score of >8 on the WHO Alcohol Use).