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

NCT ID: NCT01318096

Last Updated: 2011-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-09-30

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.

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.

Conditions

HBV Coinfection; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A:Raltegravir + tenofovir+lamivudine

Group Type: EXPERIMENTAL

raltegravir and tenofovir and lamivudine

Intervention Type: DRUG

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

B:Efavirenz+tenofovir+lamivudine

Group Type: ACTIVE_COMPARATOR

efavirenz+tenofovir+lamivudine

Intervention Type: DRUG

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

Interventions

raltegravir and tenofovir and lamivudine

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

Intervention Type: DRUG

efavirenz+tenofovir+lamivudine

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

Intervention Type: DRUG

Other Intervention Names

raltegravir: Isentress; efavirenz: Sustiva

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yunnan AIDS Care Center

OTHER

Sponsor Role: lead

Responsible Party

Yunnan Provincial Hospital of Infectious Diseases/Yunnan AIDS Care Center

Principal Investigators

Cheng Xi Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yunnan Provincial Hospital of Infectious Diseases/Yunnan AIDS Care Center

Locations

Yunnan Provincial Hospital of Infectious Diseases/Yunnan AIDS Care Center

Kunming, Yunnan Provice, China

Countries

China

Facility Contacts

Cheng Xi Wang, M.D.

Role: primary

wxch62597@foxmail.com

86 871 8728060

Other Identifiers

MSD-38154

Identifier Type: -

Identifier Source: org_study_id