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

NCT01318096 | Unknown

• 1 other identifier: MSD-38154
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HBV Coinfection; HIV Infections

Keywords

safety; efficacy; raltegravir; HBV/HIV co-infection

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (15)

• Change of plasma HIV-1 RNA levels

  week 0,24 and 48

• Change of Peripheral blood CD4 cell counts

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

• Change of plasma HBV-DNA levels

  week 0,12,24,36,and 48

• Change of serum total bilirubin levels（TBI）

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

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

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

Study Arms (2)

A:Raltegravir + tenofovir+lamivudine

EXPERIMENTAL

Drug: raltegravir and tenofovir and lamivudine

B:Efavirenz+tenofovir+lamivudine

ACTIVE COMPARATOR

Drug: efavirenz+tenofovir+lamivudine

Interventions

raltegravir and tenofovir and lamivudine DRUG

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

Also known as: raltegravir: Isentress

A:Raltegravir + tenofovir+lamivudine

efavirenz+tenofovir+lamivudine DRUG

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

Also known as: efavirenz: Sustiva

B:Efavirenz+tenofovir+lamivudine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yunnan AIDS Care Center: lead

Study Sites (1)

Yunnan Provincial Hospital of Infectious Diseases/Yunnan AIDS Care Center

Kunming, Yunnan Provice, 650301, China

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium; Tenofovir; Lamivudine; efavirenz, lamivudine, tenofovir disoproxil fumarate drug combination; efavirenz

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Cheng Xi Wang, M.D.

  Yunnan Provincial Hospital of Infectious Diseases/Yunnan AIDS Care Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 18, 2011
• Study Start: March 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2013
• Last Updated: March 18, 2011

Record last verified: 2011-03

Locations

CN (1)