Trials Sponsors Conditions Drugs Pricing

Conditions

Hepatitis B HIV Infections

Keywords

HIVHepatitis Btreatment experienced

Outcome Measures

Primary Outcomes (1)

Hepatitis B Virus (HBV) DNA
HBV DNA carries the genetic blueprint of the virus. How many HBV DNA "particles" or "copies" are found in the blood indicates how rapidly the virus is reproducing in the liver.
week 24

Secondary Outcomes (4)

Incidence of Permanent Discontinuation Due to Toxicity
24 weeks
Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy)
every 4 weeks for 24 weeks
Incidence of ALT Flares
every 4 weeks for 24 weeks
HIV RNA < 75 Copies/ml
entry, week 12, and week 24

Study Arms (2)

A

EXPERIMENTAL

Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine

Drug: Entecavir with continued standard of care antiretroviral therapy

B

ACTIVE COMPARATOR

continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine

Drug: continued standard of care with tenofovir in addition to emtricitabine or lamivudine

Interventions

Entecavir with continued standard of care antiretroviral therapyDrug

1 mg by mouth daily

Also known as: Baraclude, Tenofovir, Truvada, Viread, 3TC, FTC, Epivir, Emtriva

continued standard of care with tenofovir in addition to emtricitabine or lamivudineDrug

continued standard of care with tenofovir in addition to emtricitabine or lamivudine

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Partially structured registry wording
Entecavir with continued standard of care antiretroviral therapy
Part of this registry label remains unresolved and is preserved as written. Recognized names are text references, not confirmed ingredients. Composition, doses and actual exposure are not established.
Names joined in the label
1 recognized name reference in the wording; 1 unresolved part.
View registry record
Grouped treatment entry
continued standard of care with tenofovir in addition to emtricitabine or lamivudine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ability and willingness to provide written informed consent
HIV infection, documented in patient medical record. Acceptable forms of documentation include positive HIV antibody or detectable HIV RNA.

Sponsors & Collaborators

University of California, San Francisco
Otherlead
Bristol-Myers Squibb
Industrycollaborator

Study Sites (1)

San Francisco General HIV Clinical Trials Group

San Francisco, California, 94110, United States

Related Publications (18)

Thio CL, Seaberg EC, Skolasky R Jr, Phair J, Visscher B, Munoz A, Thomas DL; Multicenter AIDS Cohort Study. HIV-1, hepatitis B virus, and risk of liver-related mortality in the Multicenter Cohort Study (MACS). Lancet. 2002 Dec 14;360(9349):1921-6. doi: 10.1016/s0140-6736(02)11913-1.
PMID: 12493258BACKGROUND
Konopnicki D, Mocroft A, de Wit S, Antunes F, Ledergerber B, Katlama C, Zilmer K, Vella S, Kirk O, Lundgren JD; EuroSIDA Group. Hepatitis B and HIV: prevalence, AIDS progression, response to highly active antiretroviral therapy and increased mortality in the EuroSIDA cohort. AIDS. 2005 Mar 24;19(6):593-601. doi: 10.1097/01.aids.0000163936.99401.fe.
PMID: 15802978BACKGROUND

MeSH Terms

Conditions

HIV InfectionsHepatitis B

Interventions

entecavirTenofovirEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationRacivirLamivudineEmtricitabine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus Infections

Results Point of Contact

Title: Anne Luetkemeyer
Organization: UCSF SFGH

Study Officials

Anne F Luetkemeyer, MD
HIV/AIDS Division, San Francisco General Hospital, University of California, San Francisco
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 16, 2008

First Posted

April 21, 2008

Study Start

April 2008

Date type not reported

This date has not been verified as actual or estimated.

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
Prisoners or subjects who are incarcerated.
Evidence of malignancy that would make the subject, in the opinion of the investigator, unsuitable for the study. This includes any systemic antineoplastic or immunomodulatory treatment or radiation within 24 weeks prior to study entry or the expectation that such treatment will be needed at any time during the study.
Receipt of systemic corticosteroids within 90 days prior to study entry (as this medication may increase HBV replication).
Investigational anti-HIV agents will be allowed on a case-by-case basis with the approval of the protocol team.
Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
Any active medical, psychiatric or social circumstance that in the opinion of the investigator puts the subject at potential risk from study participation or makes adherence to the study protocol unlikely.
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: adefovir(ADV), telbivudine, alpha interferon, penciclovir (Denavir) (except if given for \< 4 weeks), famciclovir (Famvir), diaminopurine dioxolane (DAPD), clevudine (L-FMAU), thymosin alpha 1, ganciclovir (treatment limited to \< 7 days is acceptable) (Cytovene), L-deoxythymidine, and L-deoxythymidine compounds and other investigational agents with anti-HBV activity.
Receipt of nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, vancomycin, cidofovir \[Vistide\], foscarnet \[Foscavir\], cisplatin, intravenous pentamidine \[Pentam\], oral tacrolimus \[Prograf\], cyclosporine \[Sandimmune\]) or the competitor of renal excretion, probenecid (Benemid), within 8 weeks prior to study entry or expected use of these agents during the course of the study. (Topical tacrolimus is allowed.)

Entecavir Intensification for Persistent HBV Viremia in HIV-HBV Infection

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

A

B

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (18)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

A

B

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (18)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations