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Safety Study of a Tenofovir-containing Drug Regimen for the Prevention of Mother-to-child Transmission of HIV and HBV

NCT01125696 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-07-15

No results posted yet for this study

Summary

The purpose of this study is to compare a regimen of tenofovir/lamivudine/lopinavir-ritonavir to the WHO-recommended and locally practiced standard of care regimen consisting of zidovudine/lamivudine/lopinavir-ritonavir during the second and third trimesters of pregnancy in HIV and HBV co-infected women. This is a phase II study evaluating the safety of the test regimen in pregnant women and their newborns. While the study is not powered to examine efficacy, preliminary estimates of transmission of HIV and HBV to the infants and of the rate of resistance development will be obtained.

Conditions

Interventions

DRUG

Tenofovir/lamivudine/lopinavir-ritonavir

Tenofovir/lamivudine/lopinavir-ritonavir given to mothers starting at 14-28 weeks gestation till labor/delivery and continued postpartum if maternal baseline CD4\<350

DRUG

Zidovudine/lamivudine/lopinavir-ritonavir

Zidovudine/lamivudine/lopinavir-ritonavir given to mothers starting at 14-28 weeks gestation till labor/delivery and continued postpartum if maternal baseline CD4\<350

Sponsors & Collaborators

Principal Investigators

  • Athena P Kourtis, MD, PhD, MPH · Centers for Disease Control and Prevention, Division of Reproductive Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2018-05-31
Completion
2018-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01125696 on ClinicalTrials.gov