HIV Clinical Trial
— TiPOfficial title:
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
Verified date | July 2020 |
Source | Centers for Disease Control and Prevention |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | August 2018 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Liuzhou MCH Hospital | Liuzhou | Guangxi |
China | Guangxi MCH Hospital | Nanning | Guangxi |
Lead Sponsor | Collaborator |
---|---|
Centers for Disease Control and Prevention | National Center for AIDS/STD Control and Prevention, China CDC |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Maternal Tenofovir Pharmacokinetics | Only for mothers on the active arm. | 16 weeks gestation through delivery | |
Primary | Infant Tenofovir Pharmacokinetics | Only for infants on the active arm. | one timepoint within 12 hours of delivery | |
Primary | 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 | HBV viral load in mothers | from baseline (14-28 weeks gestation) through delivery | ||
Secondary | Infant HIV transmission rate | birth through 12 months | ||
Secondary | Infant HBV transmission rate | birth through 12 months | ||
Secondary | Prevalence of HIV resistance mutations | from baseline (14-28 weeks gestation) through 12 months postpartum | ||
Secondary | Prevalence of HBV resistance mutations | from baseline (14-28 weeks gestation) through 12 months postpartum |
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