HIVPhase 2TiPNCT01125696

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

A Phase 2 study testing Tenofovir/lamivudine/lopinavir-ritonavir and Zidovudine/lamivudine/lopinavir-ritonavir in people with HIV and Hepatitis B, run by Centers for Disease Control and Prevention at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 years and older, women only
Conditions the study is for: HIV, Hepatitis B
What is being tested?: Tenofovir/lamivudine/lopinavir-ritonavir and Zidovudine/lamivudine/lopinavir-ritonavir
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 2 sitesChina
Study dates: May 2012to Aug 2018
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

China2 sites

Liuzhou MCH Hospital
Liuzhou, Guangxi
Guangxi MCH Hospital
Nanning, Guangxi

Other trials in China

About this study

Official 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

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.

Read the detailed description

Great progress has been made in preventing mother-to-child transmission (MTCT) of HIV in resource-rich settings with the use of combination antiretroviral regimens during pregnancy and peripartum. In the resource-limited world simple inexpensive regimens administered peripartum, such as single dose nevirapine to mothers and infants, have been effective in reducing transmission but at the cost of development of resistance. Strategies that will allow women to preserve their antiretroviral options when they will need therapy for their own HIV disease and will improve efficacy are urgently needed. Moreover, co-infection with hepatitis B virus (HBV) is a problem for a substantial proportion of HIV-infected pregnant women. HIV alters the course of HBV disease by increasing levels of HBV DNA replication and thus risk of transmission to the newborn. HBV immunization in the infant with the first dose started soon after birth has decreased the bulk of such transmission, but the risk remains, particularly for mothers with HBe antigen positivity. Ideally an antiviral regimen administered during pregnancy with activity against both viruses would minimize transmission of both HIV and HBV to the infant.

The investigators propose to study a combination of tenofovir/lamivudine/lopinavir-ritonavir started between 14 and 28 weeks of pregnancy in HIV and HBV co-infected women. This regimen provides potent antiviral activity for prevention of MTCT. In addition, tenofovir and lamivudine both have activity against HBV, and could play a role in decreasing transmission of HBV to the infant. This regimen will be compared to the WHO-recommended and locally practiced standard of care, consisting of zidovudine/lamivudine/lopinavir-ritonavir, also starting at 14-28 weeks of pregnancy. This will be a phase II study evaluating the safety of the test regimen in pregnant women and their newborns, in particular renal, bone mineral density and hepatic toxicity (including hepatic flares post discontinuation of therapy). The study will recruit 80 pregnant women of at least 20 years of age in China and follow them and their infants for 12 months post-delivery. The investigators will recruit from prenatal clinics in some of the districts most heavily affected by HIV in the Guangxi province in China. China is selected for this study as it is hyperendemic for hepatitis B and has a rising HIV epidemic. Although 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. The study will be done in collaboration with CDC-GAP China and the Chinese Ministry of Health-National Center for AIDS, which will coordinate recruitment, study visits and data collection through the local HIV/AIDS coordinators.

Conditions: HIV, Hepatitis B
Being tested: Tenofovir/lamivudine/lopinavir-ritonavir, Zidovudine/lamivudine/lopinavir-ritonavir
Keywords: mother-to-child transmission, HIV, Hepatitis B, Pregnant women, Tenofovir, Infants
Medical subject headings: Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01125696
Study group	Role	What they receive
Standard of Care	Active comparator	Not described Receives: Drug: Zidovudine/lamivudine/lopinavir-ritonavir
Tenofovir	Experimental	Not described Receives: Drug: Tenofovir/lamivudine/lopinavir-ritonavir

What is being measured

The primary outcome is the main question the study is designed to answer.

Tenofovir Safety for mothers measured by incidence of serious adverse events (SAEs)
SAEs will be defined using the DAIDS Toxicity Tables
Measured: 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.
Measured: from delivery through 6 months postpartum
Maternal Tenofovir Pharmacokinetics
Only for mothers on the active arm.
Measured: 16 weeks gestation through delivery
Infant Tenofovir Pharmacokinetics
Only for infants on the active arm.
Measured: 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.
Measured: from birth through 12 months of age

Secondary outcomes (5)

HBV viral load in mothers
Measured: from baseline (14-28 weeks gestation) through delivery
Infant HIV transmission rate
Measured: birth through 12 months
Infant HBV transmission rate
Measured: birth through 12 months
Prevalence of HIV resistance mutations
Measured: from baseline (14-28 weeks gestation) through 12 months postpartum
Prevalence of HBV resistance mutations
Measured: from baseline (14-28 weeks gestation) through 12 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Aug 2018

First posted18 May 2010 (estimated)
Study startMay 2012
Primary completionMay 2018
Study completionAug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01125696
Sponsor's protocol ID: CDC-NCCDPHP-5877
Acronym: TiP
Status last verified: Jul 2020
First submitted: 29 Mar 2010
Last updated: 15 Jul 2020
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 27658693

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT01125696
Acronym / sponsor ID: TiP / CDC-NCCDPHP-5877
Conditions: HIV, Hepatitis B
Keywords: mother-to-child transmission, HIV, Hepatitis B, Pregnant women, Tenofovir, Infants
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Centers for Disease Control and PreventionUS federal agency
Collaborators: National Center for AIDS/STD Control and Prevention, China CDC
Study start: May 2012
Primary completion: May 2018 (actual)
Study completion: Aug 2018 (actual)
First posted: 18 May 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard of Care	Active comparator	Drug: Zidovudine/lamivudine/lopinavir-ritonavir
Tenofovir	Experimental	Drug: Tenofovir/lamivudine/lopinavir-ritonavir

Who may qualify

Ages: 20 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tenofovir/lamivudine/lopinavir-ritonavirTenofovir/lamivudine/lopinavir-ritonavir given to mothers starting at 14-28 weeks gestation till labor/delivery and continued postpartum if maternal baseline CD4<350	Drug	Tenofovir
Zidovudine/lamivudine/lopinavir-ritonavirZidovudine/lamivudine/lopinavir-ritonavir given to mothers starting at 14-28 weeks gestation till labor/delivery and continued postpartum if maternal baseline CD4<350	Drug	Standard of Care

Primary outcome

Tenofovir Safety for mothers measured by incidence of serious adverse events (SAEs)
Time frame: From baseline (14-28 weeks gestation) through 12 months postpartum
SAEs will be defined using the DAIDS Toxicity Tables
Dual Energy X-ray absorptiometry (DXA) scans of bone mineral density
Time frame: from delivery through 6 months postpartum
Mothers will have DXA scan of hip and lumbar spine. Infants will have DXA scan of whole body and lumbar spine.
Maternal Tenofovir Pharmacokinetics
Time frame: 16 weeks gestation through delivery
Only for mothers on the active arm.
Infant Tenofovir Pharmacokinetics
Time frame: one timepoint within 12 hours of delivery
Only for infants on the active arm.
Tenofovir safety for infants measured by incidence of serious adverse events (SAEs)
Time frame: from birth through 12 months of age
SAEs defined according to the DAIDS toxicity tables.

5 secondary outcomes

HBV viral load in mothers
Time frame: from baseline (14-28 weeks gestation) through delivery
Infant HIV transmission rate
Time frame: birth through 12 months
Infant HBV transmission rate
Time frame: birth through 12 months
Prevalence of HIV resistance mutations
Time frame: from baseline (14-28 weeks gestation) through 12 months postpartum
Prevalence of HBV resistance mutations
Time frame: from baseline (14-28 weeks gestation) through 12 months postpartum

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
Derived from this study: PubMed 27658693Wang 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Athena P Kourtis, MD, PhD, MPH principal investigator

Centers for Disease Control and Prevention, Division of Reproductive Health

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tenofovir Safety for mothers measured by incidence of serious adverse events (SAEs) (time frame: From baseline (14-28 weeks gestation) through 12 months postpartum). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01125696, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.