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HBV CoinfectionNCT01318096

Safety and Efficacy of Raltegravir+TDF+3TC in HBV/HIV Co-infected Patients

A study testing raltegravir and tenofovir and lamivudine and efavirenz+tenofovir+lamivudine in people with HBV Coinfection and HIV Infections, run by Yunnan AIDS Care Center at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this pilot study, the investigators would examine the safety and efficacy of integrase inhibitor-Raltegravir in the control of HIV/HBV co-infection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HBV Coinfection, HIV Infections
What is being tested?
raltegravir and tenofovir and lamivudine and efavirenz+tenofovir+lamivudine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
Mar 2011to Sep 2013
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability and willingness to provide written informed consent
  • HIV-1 infection, documented in patient medical record. Acceptable forms of documentation include positive HIV antibody or detectable HIV RNA
  • HIV-1 antiretroviral therapy naïve
  • Chronic HBV infection, defined as HBsAg positive >6 months. Both HBeAg positive and negative subjects will be eligible
  • Detectable HBV DNA ( > 300 copies/ml)
  • Serum alpha-fetoprotein (AFP) of ≤ 50 ng/ml within 4 weeks of study entry, or if elevated > 50 ng/ml, an imaging study demonstrating no evidence of hepatic tumor within 4 weeks of enrollment

Who cannot join

  • Allergy or sensitivity to study drug
  • Pregnancy, breastfeeding or unwillingness/inability to adhere to contraceptive methods for the duration of the study (Female study volunteers must not participate in a conception process (e.g., active attempt to become pregnant). If participating in sexual activity that could lead to pregnancy, the female study volunteer must use the following forms of contraception while receiving study-specific medication(s) and for 30 days after stopping the medication. One of the following methods MUST be used appropriately: (1)Condoms* (male or female) with or without a spermicidal agent; (2)Diaphragm or cervical cap with spermicide; (3)IUD; (4)Hormonal-based method.Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV transmission.
  • Prisoners or subjects who are incarcerated
  • Receipt of the following drugs with anti-HBV activity within 90 days prior to study entry or anticipated receipt during the course of the study including: ADV, telbivudine, alpha interferon, and other investigational agents with anti-HBV activity
  • Active opportunistic infection
  • Other causes of chronic liver disease identified (autoimmune hepatitis, haemochromatosis, Wilsons disease, alfa-1-antitrypsin deficiency)
Show all 9Show fewer
  • Concurrent malignancy requiring cytotoxic chemotherapy
  • Decompensated or Child's C cirrhosis
  • Any other condition which in the opinion of the investigator might interfere with compliance or outcome of the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Yunnan Provincial Hospital of Infectious Diseases/Yunnan AIDS Care Center

    Kunming, Yunnan Provice, 650301

    Cheng Xi Wang, M.D., 86 871 8728060, wxch62597@foxmail.com

    Cheng Xi Wang, M.D.

Other trials in China

About this study

Official title: A Randomized, Pilot Estimation Study to Compare the Safety and Efficacy of Raltegravir+TDF+3TC Versus TDF+3TC+EFV in HBV/HIV Co-infected Patients

In this pilot study, the investigators would examine the safety and efficacy of integrase inhibitor-Raltegravir in the control of HIV/HBV co-infection.

Read the detailed description

There are in total more than 72939 HIV infected people reported in Yunnan, the largest number for any province in China. About 800 HIV inpatients are admitted to our hospital every year, amongst them about 10% co-infected with HBV. HIV and HBV co-infection patients must receive two drugs active against both HIV and HBV, for example Tenofovir disoproxil fumarate (TDF)+ lamivudine (3TC) or TDF+FTC. TDF and 3TC are nucleotide analogues that can inhibit both HIV and HBV DNA polymerases (Dore, Cooper et al. 2004). Combination therapy could decrease drug resistance. In China, TDF is a second-line drug of the national free ART program; however FTC is not in the list of free drugs. There is likely higher risk of causing drug resistance in treating HBV or HIV infection with 3TC or TDF monotherapy than combination therapy.

Raltegravir inhibits the catalytic activity of HIV-1 integrase, and does not significantly inhibit human phosphoryl transferases including DNA polymerases α, β, and γ, and may have less adverse effects. In chronic HBV infection, HBV-DNA does integrate into human DNA which results in difficulty eradicating HBV from the patient's body.

In this pilot study, the investigators would examine the safety and efficacy of integrase inhibitor-Raltegravir in the control of HIV/HBV co-infection.

Being tested
raltegravir and tenofovir and lamivudine, efavirenz+tenofovir+lamivudine
Keywords
safety, efficacy, raltegravir, HBV/HIV co-infection
Medical subject headings
HIV Infections

What participants receive

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

  • raltegravir and tenofovir and lamivudineDrug

    Also called raltegravir: Isentress

    raltegravir 400mg BID and tenofovir 300mg qd and lamivudine 300mg gd for 48 weeks

  • efavirenz+tenofovir+lamivudineDrug

    Also called efavirenz: Sustiva

    efavirenz 600mg QN +tenofovir 300mg qd +lamivudine 300mg qd for 48 weeks

Study groups in NCT01318096
Study groupRoleWhat they receive
A:Raltegravir + tenofovir+lamivudineExperimentalNot described
Receives: Drug: raltegravir and tenofovir and lamivudine
B:Efavirenz+tenofovir+lamivudineActive comparatorNot described
Receives: Drug: efavirenz+tenofovir+lamivudine

What is being measured

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

  1. Frequency and severity of adverse events

    The investigators will collect the adverse events at every follow-up, and record them in CRFs. All AEs during the study will be analyzed according to the type, frequency and severity.

    Measured: In 48 weeks (from baseline to study completion at 48 weeks)

Secondary outcomes (15)

  1. Change of plasma HIV-1 RNA levels

    Measured: week 0,24 and 48

  2. Change of Peripheral blood CD4 cell counts

    Measured: week 0,4,8,12,24,36 and 48

  3. Change of plasma HBV-DNA levels

    Measured: week 0,12,24,36,and 48

  4. Change of serum total bilirubin levels（TBI）

    Measured: week 0,2,4,8,12,24,36 and 48

  5. Proportion of subjects with HBeAg seroconversion (HBeAg loss and presence of anti HBe)

    Measured: week 0,12,24,36,and week 48

  6. Emergence of drug resistance mutations, if appropriate

    Measured: week 0, 24 and 48

  7. Paired liver biopsy comparison according to inflammatory activity and fibrosis score

    Measured: week 0 and 48

  8. Change of serum alanine aminotransferase levels (ALT)

    Measured: week 0,2,4,8,12,24,36 and 48

  9. Change of serum aspartate aminotransferase levels (AST)

    Measured: week 0,2,4,8,12,24,36 and 48

  10. Change of blood urine nitrogen levels (BUN)

    Measured: week 0,2,4,8,12,24,36 and 48

  11. Change of serum creatinine levels (SCr)

    Measured: week 0,2,4,8,12,24,36 and 48

  12. Change of blood haemoglobin levels (HB)

    Measured: week 0,2,4,8,12,24,36 and 48

  13. Change of white blood cell counts (WBC)

    Measured: week 0,2,4,8,12,24,36 and 48

  14. Change of blood platelet counts (PLT)

    Measured: week 0,2,4,8,12,24,36 and 48

  15. Change of urine protein levels

    Measured: week 0,2,4,8,12,24,36 and 48

Timeline

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

  1. First posted18 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionJul 2012 (estimated)
  4. Study completionSep 2013 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01318096
Sponsor's protocol ID
MSD-38154
Status last verified
Mar 2011
First submitted
8 Mar 2011
Last updated
18 Mar 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing raltegravir and tenofovir and lamivudine and efavirenz+tenofovir+lamivudine in people with HBV Coinfection and HIV Infections, run by Yunnan AIDS Care Center at 1 site in China.

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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and severity of adverse events (time frame: In 48 weeks (from baseline to study completion at 48 weeks)). 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 NCT01318096.

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 18 Mar 2011; AzTrials last refreshed its copy on 8 Nov 2026.

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