Status:
COMPLETED
Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women
Lead Sponsor:
University of KwaZulu
Collaborating Sponsors:
Centre for the AIDS Programme of Research in South Africa
Medical Research Council, South Africa
Conditions:
HIV-1-infection
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
PHASE3
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 participat...
Detailed Description
Background: It is becoming increasingly evident that women remain vulnerable to HIV infection during pregnancy and even more so postdelivery. In a meta-analysis, using data from 19 international coho...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT03227731
Start Date
September 28 2017
End Date
December 30 2021
Last Update
November 7 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of KwaZulu-Natal
Durban, KwaZulu-Natal, South Africa, 4001