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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Yunnan AIDS Care Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Yunnan AIDS Care Center
ClinicalTrials.gov Identifier:
NCT01318096
First received: March 8, 2011
Last updated: March 17, 2011
Last verified: March 2011

March 8, 2011
March 17, 2011
March 2011
July 2012   (final data collection date for primary outcome measure)
Frequency and severity of adverse events [ Time Frame: In 48 weeks (from baseline to study completion at 48 weeks) ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01318096 on ClinicalTrials.gov Archive Site
  • Change of plasma HIV-1 RNA levels [ Time Frame: week 0,24 and 48 ] [ Designated as safety issue: No ]
  • Change of Peripheral blood CD4 cell counts [ Time Frame: week 0,4,8,12,24,36 and 48 ] [ Designated as safety issue: No ]
  • Change of plasma HBV-DNA levels [ Time Frame: week 0,12,24,36,and 48 ] [ Designated as safety issue: No ]
  • Change of serum total bilirubin levels(TBI) [ Time Frame: week 0,2,4,8,12,24,36 and 48 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with HBeAg seroconversion (HBeAg loss and presence of anti HBe) [ Time Frame: week 0,12,24,36,and week 48 ] [ Designated as safety issue: No ]
  • Emergence of drug resistance mutations, if appropriate [ Time Frame: week 0, 24 and 48 ] [ Designated as safety issue: No ]
  • Paired liver biopsy comparison according to inflammatory activity and fibrosis score [ Time Frame: week 0 and 48 ] [ Designated as safety issue: No ]
  • Change of serum alanine aminotransferase levels (ALT) [ Time Frame: week 0,2,4,8,12,24,36 and 48 ] [ Designated as safety issue: Yes ]
  • Change of serum aspartate aminotransferase levels (AST) [ Time Frame: week 0,2,4,8,12,24,36 and 48 ] [ Designated as safety issue: Yes ]
  • Change of blood urine nitrogen levels (BUN) [ Time Frame: week 0,2,4,8,12,24,36 and 48 ] [ Designated as safety issue: Yes ]
  • Change of serum creatinine levels (SCr) [ Time Frame: week 0,2,4,8,12,24,36 and 48 ] [ Designated as safety issue: Yes ]
  • Change of blood haemoglobin levels (HB) [ Time Frame: week 0,2,4,8,12,24,36 and 48 ] [ Designated as safety issue: Yes ]
  • Change of white blood cell counts (WBC) [ Time Frame: week 0,2,4,8,12,24,36 and 48 ] [ Designated as safety issue: Yes ]
  • Change of blood platelet counts (PLT) [ Time Frame: week 0,2,4,8,12,24,36 and 48 ] [ Designated as safety issue: Yes ]
  • Change of urine protein levels [ Time Frame: week 0,2,4,8,12,24,36 and 48 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HBV Coinfection
  • HIV Infections
  • Drug: raltegravir and tenofovir and lamivudine
    raltegravir 400mg BID and tenofovir 300mg qd and lamivudine 300mg gd for 48 weeks
    Other Name: raltegravir: Isentress
  • Drug: efavirenz+tenofovir+lamivudine
    efavirenz 600mg QN +tenofovir 300mg qd +lamivudine 300mg qd for 48 weeks
    Other Name: efavirenz: Sustiva
  • Experimental: A:Raltegravir + tenofovir+lamivudine
    Intervention: Drug: raltegravir and tenofovir and lamivudine
  • Active Comparator: B:Efavirenz+tenofovir+lamivudine
    Intervention: Drug: efavirenz+tenofovir+lamivudine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
September 2013
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
China
 
NCT01318096
MSD-38154
No
Xi-cheng Wang, Yunnan Provincial Hospital of Infectious Diseases/Yunnan AIDS Care Center
Yunnan AIDS Care Center
Not Provided
Principal Investigator: Cheng Xi Wang, M.D. Yunnan Provincial Hospital of Infectious Diseases/Yunnan AIDS Care Center
Yunnan AIDS Care Center
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP