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

NCT03227731 | Completed Phase 2 DMC

• 1 other identifier: UKwaZulu
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV-1-infection

Keywords

Preexposure prophylaxis; safety; HIV prevention; pregnant women; lactating women

Outcome Measures

Primary Outcomes (3)

• Pregnancy Outcome-Preterm Deliveries

  Number of preterm deliveries \< 37 weeks gestation

  Within 72 hours postdelivery

• Bone Mineral Density in mother and infant

  Number of participants with decreased bone mineral density of hip and spine

  6 weeks postdelivery, and thereafter 6 monthly until week 74

• Pregnancy Outcome-Low Birth Weight

  Number of Low birth weight babies \<2500g

  Within 72 hours

Other Outcomes (2)

• Incident HIV infection

  Monthly during pregnancy and until 74 weeks postdelivery

• Adherence to PrEP

  Monthly during pregnancy and until 74 weeks postdelivery

Study Arms (2)

Arm A (Intervention - Truvada)

ACTIVE COMPARATOR

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.

Drug: Truvada

Arm B (Control - Standard of Care)

NO INTERVENTION

Standard HIV Prevention strategy throughout pregnancy until 18 months postdelivery plus the offer to initiate PrEP post breastfeeding cessation

Interventions

Truvada DRUG

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.

Also known as: emtricitabine 200mg/tenofovir disoproxil fumarate 300mg)

Arm A (Intervention - Truvada)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of KwaZulu: lead
• Centre for the AIDS Programme of Research in South Africa: collaborator
• Medical Research Council, South Africa: collaborator

Study Sites (1)

University of KwaZulu-Natal

Durban, KwaZulu-Natal, 4001, South Africa

Location

Related Publications (2)

• Khoza N, Desmond AC, Moodley D. Adherence to Oral HIV Pre-exposure Prophylaxis During Pregnancy and the Post-partum Period: Lessons Learned in an Open-Labelled Clinical Trial. AIDS Behav. 2025 Nov 15. doi: 10.1007/s10461-025-04952-z. Online ahead of print.

  PMID: 41240274 DERIVED

• Moodley D, Lombard C, Govender V, Naidoo M, Desmond AC, Naidoo K, Mhlongo O, Sebitloane M, Newell ML, Clark R, Rooney JF, Gray G; CAP016 Team. Pregnancy and neonatal safety outcomes of timing of initiation of daily oral tenofovir disoproxil fumarate and emtricitabine pre-exposure prophylaxis for HIV prevention (CAP016): an open-label, randomised, non-inferiority trial. Lancet HIV. 2023 Mar;10(3):e154-e163. doi: 10.1016/S2352-3018(22)00369-1. Epub 2023 Feb 3.

  PMID: 36746169 DERIVED

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Tenofovir

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Dhayendre Moodley, PhD

  University of KwaZulu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 24, 2017
• Study Start: September 28, 2017
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)