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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 : May 15, 2018
Sponsor:
Collaborators:
Centre for the AIDS Programme of Research in South Africa
Medical Research Council, South Africa
Information provided by (Responsible Party):
Dhayendre Moodley, PhD, University of KwaZulu

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, STI screening and treatment, condom promotion and inviting the sexual partner to receive HCT and referral for 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
Allocation: Randomized
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)
Primary Purpose: Other
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 : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
Drug: Truvada
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



Primary Outcome Measures :
  1. Pregnancy Outcome-Preterm Deliveries [ Time Frame: Within 72 hours postdelivery ]
    Number of preterm deliveries < 37 weeks gestation

  2. 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

  3. Pregnancy Outcome-Low Birth Weight [ Time Frame: Within 72 hours ]
    Number of Low birth weight babies <2500g


Other Outcome Measures:
  1. Incident HIV infection [ Time Frame: Monthly during pregnancy and until 74 weeks postdelivery ]
    Number of Incident HIV infections in women

  2. Adherence to PrEP [ Time Frame: Monthly during pregnancy and until 74 weeks postdelivery ]
    Number of women with >90% adherence to PrEP



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
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 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
    • WBC < 1500 cells/mm3
    • ANC < 750 cells/mm3
    • Platelets < 100,000 cells/mm3
    • ALT > 2.5 x upper limit of normal (ULN)
    • Estimated creatinine clearance of < 70mL/min using the Cockroft-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).

Information from the National Library of Medicine

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


Contacts
Contact: Dhayendre Moodley, PhD +27(0)312604685 moodleyd1@ukzn.ac.za
Contact: Vani Govender, BTechHons +27(0)312601998 chettyv1@ukzn.ac.za

Locations
South Africa
University of KwaZulu-Natal Recruiting
Durban, KwaZulu-Natal, South Africa, 4001
Contact: Karen Reinertsen    +27(0)312608850    reinertsenk@ukzn.ac.za   
Sponsors and Collaborators
University of KwaZulu
Centre for the AIDS Programme of Research in South Africa
Medical Research Council, South Africa
Investigators
Principal Investigator: Dhayendre Moodley, PhD University of KwaZulu
  Study Documents (Full-Text)

Documents provided by Dhayendre Moodley, PhD, University of KwaZulu:

Responsible Party: Dhayendre Moodley, PhD, Professor, University of KwaZulu
ClinicalTrials.gov Identifier: NCT03227731     History of Changes
Other Study ID Numbers: UKwaZulu
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dhayendre Moodley, PhD, University of KwaZulu:
Preexposure prophylaxis
safety
HIV prevention
pregnant women
lactating women

Additional relevant MeSH terms:
Anti-HIV Agents
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents