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

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Collaborator: National Center for AIDS/STD Control and Prevention, China CDC
• Treatments: Lamivudine; Lopinavir; Ritonavir; Tenofovir; Zidovudine

Criteria

Inclusion Criteria:

• Serologically-confirmed HIV and HBV infection

• Gestational age less than 28 weeks

• Willingness to participate in a clinical trial

• Age 20 years or over on the day of inclusion

• Willingness to return for follow-up visits and to allow infant participation in the trial

• Intent to remain in the clinic catchment area during the duration of the study

• No serious current complications of pregnancy

• No previous or current use of antiretrovirals including the HIVNET 012 regiment

• Hemoglobin over 8 g/dL

• Blood creatinine clearance greater than or equal to 60 mL/min estimated by the Cockroft-Gault formula for women

Exclusion Criteria:

• Age less than 20

• Pregnant woman refuses to sign the consent to participate

• Unwillingness to adhere to visit schedule or maintain adherence with medications

• Illnesses so severe as to likely require maternal hospitalization

• Intend to breastfeed