NCT01318096

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Yunnan AIDS Care Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	raltegravir and tenofovir and lamivudine	raltegravir 400mg BID and tenofovir 300mg qd and lamivudine 300mg gd for 48 weeks
DRUG	efavirenz+tenofovir+lamivudine	efavirenz 600mg QN +tenofovir 300mg qd +lamivudine 300mg qd for 48 weeks

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-07-01
• Completion: 2013-09-01
• First posted: 2011-03-18
• Last updated: 2011-03-18

Locations

1 site across 1 country: China