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

17. marts 2011 opdateret af: Yunnan AIDS Care Center

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Yunnan Provice
      • Kunming, Yunnan Provice, Kina, 650301
        • Yunnan Provincial Hospital of Infectious Diseases/Yunnan AIDS Care Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: A:Raltegravir + tenofovir+lamivudine
Medicin: raltegravir and tenofovir and lamivudine
raltegravir 400mg BID and tenofovir 300mg qd and lamivudine 300mg gd for 48 weeks
Andre navne:
  • raltegravir: Isentress
Aktiv komparator: B:Efavirenz+tenofovir+lamivudine
Medicin: efavirenz+tenofovir+lamivudine
efavirenz 600mg QN +tenofovir 300mg qd +lamivudine 300mg qd for 48 weeks
Andre navne:
  • efavirenz: Sustiva

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Frequency and severity of adverse events
Tidsramme: 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.
In 48 weeks (from baseline to study completion at 48 weeks)

Sekundære resultatmål

Resultatmål
Tidsramme
Change of plasma HIV-1 RNA levels
Tidsramme: week 0,24 and 48
week 0,24 and 48
Change of Peripheral blood CD4 cell counts
Tidsramme: week 0,4,8,12,24,36 and 48
week 0,4,8,12,24,36 and 48
Change of plasma HBV-DNA levels
Tidsramme: week 0,12,24,36,and 48
week 0,12,24,36,and 48
Change of serum total bilirubin levels（TBI）
Tidsramme: week 0,2,4,8,12,24,36 and 48
week 0,2,4,8,12,24,36 and 48
Proportion of subjects with HBeAg seroconversion (HBeAg loss and presence of anti HBe)
Tidsramme: week 0,12,24,36,and week 48
week 0,12,24,36,and week 48
Emergence of drug resistance mutations, if appropriate
Tidsramme: week 0, 24 and 48
week 0, 24 and 48
Paired liver biopsy comparison according to inflammatory activity and fibrosis score
Tidsramme: week 0 and 48
week 0 and 48
Change of serum alanine aminotransferase levels (ALT)
Tidsramme: week 0,2,4,8,12,24,36 and 48
week 0,2,4,8,12,24,36 and 48
Change of serum aspartate aminotransferase levels (AST)
Tidsramme: week 0,2,4,8,12,24,36 and 48
week 0,2,4,8,12,24,36 and 48
Change of blood urine nitrogen levels (BUN)
Tidsramme: week 0,2,4,8,12,24,36 and 48
week 0,2,4,8,12,24,36 and 48
Change of serum creatinine levels (SCr)
Tidsramme: week 0,2,4,8,12,24,36 and 48
week 0,2,4,8,12,24,36 and 48
Change of blood haemoglobin levels (HB)
Tidsramme: week 0,2,4,8,12,24,36 and 48
week 0,2,4,8,12,24,36 and 48
Change of white blood cell counts (WBC)
Tidsramme: week 0,2,4,8,12,24,36 and 48
week 0,2,4,8,12,24,36 and 48
Change of blood platelet counts (PLT)
Tidsramme: week 0,2,4,8,12,24,36 and 48
week 0,2,4,8,12,24,36 and 48
Change of urine protein levels
Tidsramme: week 0,2,4,8,12,24,36 and 48
week 0,2,4,8,12,24,36 and 48

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Yunnan AIDS Care Center

Efterforskere

  • Ledende efterforsker: Cheng Xi Wang, M.D., Yunnan Provincial Hospital of Infectious Diseases/Yunnan AIDS Care Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2011

Primær færdiggørelse (Forventet)

1. juli 2012

Studieafslutning (Forventet)

1. september 2013

Datoer for studieregistrering

Først indsendt

8. marts 2011

Først indsendt, der opfyldte QC-kriterier

17. marts 2011

Først opslået (Skøn)

18. marts 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. marts 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. marts 2011

Sidst verificeret

1. marts 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MSD-38154

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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