Safety Study of a Tenofovir-containing Drug Regimen for the Prevention of Mother-to-child Transmission of HIV and HBV
TiP
Maternal Tenofovir-containing Combination Drug Regimen During the Second and Third Trimesters of Pregnancy for Prevention of Mother-to-child Transmission of HIV and HBV in HIV-HBV Co-infected Mothers
1 other identifier
interventional
45
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv
Started May 2012
Longer than P75 for phase_2 hiv
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2010
CompletedFirst Posted
Study publicly available on registry
May 18, 2010
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedJuly 15, 2020
July 1, 2020
6 years
March 29, 2010
July 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Tenofovir Safety for mothers measured by incidence of serious adverse events (SAEs)
SAEs will be defined using the DAIDS Toxicity Tables
From baseline (14-28 weeks gestation) through 12 months postpartum
Dual Energy X-ray absorptiometry (DXA) scans of bone mineral density
Mothers will have DXA scan of hip and lumbar spine. Infants will have DXA scan of whole body and lumbar spine.
from delivery through 6 months postpartum
Maternal Tenofovir Pharmacokinetics
Only for mothers on the active arm.
16 weeks gestation through delivery
Infant Tenofovir Pharmacokinetics
Only for infants on the active arm.
one timepoint within 12 hours of delivery
Tenofovir safety for infants measured by incidence of serious adverse events (SAEs)
SAEs defined according to the DAIDS toxicity tables.
from birth through 12 months of age
Secondary Outcomes (5)
HBV viral load in mothers
from baseline (14-28 weeks gestation) through delivery
Infant HIV transmission rate
birth through 12 months
Infant HBV transmission rate
birth through 12 months
Prevalence of HIV resistance mutations
from baseline (14-28 weeks gestation) through 12 months postpartum
Prevalence of HBV resistance mutations
from baseline (14-28 weeks gestation) through 12 months postpartum
Study Arms (2)
Standard of Care
ACTIVE COMPARATORTenofovir
EXPERIMENTALInterventions
Tenofovir/lamivudine/lopinavir-ritonavir given to mothers starting at 14-28 weeks gestation till labor/delivery and continued postpartum if maternal baseline CD4\<350
Zidovudine/lamivudine/lopinavir-ritonavir given to mothers starting at 14-28 weeks gestation till labor/delivery and continued postpartum if maternal baseline CD4\<350
Eligibility Criteria
You may qualify if:
- Serologically-confirmed HIV and HBV infection
- Gestational age less than 28 weeks
- Willingness to participate in a clinical trial
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Liuzhou MCH Hospital
Liuchow, Guangxi, China
Guangxi MCH Hospital
Nanning, Guangxi, China
Related Publications (1)
Wang L, Wiener J, Bulterys M, Wei X, Chen L, Liu W, Liang S, Shepard C, Wang L, Wang A, Zhang F, Kourtis AP. Hepatitis B Virus (HBV) Load Response to 2 Antiviral Regimens, Tenofovir/Lamivudine and Lamivudine, in HIV/ HBV-Coinfected Pregnant Women in Guangxi, China: The Tenofovir in Pregnancy (TiP) Study. J Infect Dis. 2016 Dec 1;214(11):1695-1699. doi: 10.1093/infdis/jiw439. Epub 2016 Sep 22.
PMID: 27658693DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Athena P Kourtis, MD, PhD, MPH
Centers for Disease Control and Prevention, Division of Reproductive Health
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lead Medical Officer
Study Record Dates
First Submitted
March 29, 2010
First Posted
May 18, 2010
Study Start
May 1, 2012
Primary Completion
May 1, 2018
Study Completion
August 1, 2018
Last Updated
July 15, 2020
Record last verified: 2020-07