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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01318096
Recruitment Status : Unknown
Verified March 2011 by Yunnan AIDS Care Center.
Recruitment status was:  Not yet recruiting
First Posted : March 18, 2011
Last Update Posted : March 18, 2011
Information provided by:
Yunnan AIDS Care Center

Brief 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.

Condition or disease Intervention/treatment Phase
HBV Coinfection HIV Infections Drug: raltegravir and tenofovir and lamivudine Drug: efavirenz+tenofovir+lamivudine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : September 2013

Arm Intervention/treatment
Experimental: A:Raltegravir + tenofovir+lamivudine Drug: raltegravir and tenofovir and lamivudine
raltegravir 400mg BID and tenofovir 300mg qd and lamivudine 300mg gd for 48 weeks
Other Name: raltegravir: Isentress

Active Comparator: B:Efavirenz+tenofovir+lamivudine Drug: efavirenz+tenofovir+lamivudine
efavirenz 600mg QN +tenofovir 300mg qd +lamivudine 300mg qd for 48 weeks
Other Name: efavirenz: Sustiva

Primary Outcome Measures :
  1. Frequency and severity of adverse events [ Time Frame: In 48 weeks (from baseline to study completion at 48 weeks) ]
    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.

Secondary Outcome Measures :
  1. Change of plasma HIV-1 RNA levels [ Time Frame: week 0,24 and 48 ]
  2. Change of Peripheral blood CD4 cell counts [ Time Frame: week 0,4,8,12,24,36 and 48 ]
  3. Change of plasma HBV-DNA levels [ Time Frame: week 0,12,24,36,and 48 ]
  4. Change of serum total bilirubin levels(TBI) [ Time Frame: week 0,2,4,8,12,24,36 and 48 ]
  5. Proportion of subjects with HBeAg seroconversion (HBeAg loss and presence of anti HBe) [ Time Frame: week 0,12,24,36,and week 48 ]
  6. Emergence of drug resistance mutations, if appropriate [ Time Frame: week 0, 24 and 48 ]
  7. Paired liver biopsy comparison according to inflammatory activity and fibrosis score [ Time Frame: week 0 and 48 ]
  8. Change of serum alanine aminotransferase levels (ALT) [ Time Frame: week 0,2,4,8,12,24,36 and 48 ]
  9. Change of serum aspartate aminotransferase levels (AST) [ Time Frame: week 0,2,4,8,12,24,36 and 48 ]
  10. Change of blood urine nitrogen levels (BUN) [ Time Frame: week 0,2,4,8,12,24,36 and 48 ]
  11. Change of serum creatinine levels (SCr) [ Time Frame: week 0,2,4,8,12,24,36 and 48 ]
  12. Change of blood haemoglobin levels (HB) [ Time Frame: week 0,2,4,8,12,24,36 and 48 ]
  13. Change of white blood cell counts (WBC) [ Time Frame: week 0,2,4,8,12,24,36 and 48 ]
  14. Change of blood platelet counts (PLT) [ Time Frame: week 0,2,4,8,12,24,36 and 48 ]
  15. Change of urine protein levels [ Time Frame: week 0,2,4,8,12,24,36 and 48 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01318096

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China, Yunnan Provice
Yunnan Provincial Hospital of Infectious Diseases/Yunnan AIDS Care Center
Kunming, Yunnan Provice, China, 650301
Contact: Cheng Xi Wang, M.D.    86 871 8728060   
Principal Investigator: Cheng Xi Wang, M.D.         
Sponsors and Collaborators
Yunnan AIDS Care Center
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Principal Investigator: Cheng Xi Wang, M.D. Yunnan Provincial Hospital of Infectious Diseases/Yunnan AIDS Care Center
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Responsible Party: Xi-cheng Wang, Yunnan Provincial Hospital of Infectious Diseases/Yunnan AIDS Care Center Identifier: NCT01318096    
Other Study ID Numbers: MSD-38154
First Posted: March 18, 2011    Key Record Dates
Last Update Posted: March 18, 2011
Last Verified: March 2011
Keywords provided by Yunnan AIDS Care Center:
HBV/HIV co-infection
Additional relevant MeSH terms:
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Virus Diseases
Parasitic Diseases
Raltegravir Potassium
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers
HIV Integrase Inhibitors
Integrase Inhibitors