Trial Outcomes & Findings for Entecavir Intensification for Persistent HBV Viremia in HIV-HBV Infection (NCT NCT00662545)

NCT ID: NCT00662545

Last Updated: 2013-05-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 10 participants
• Primary outcome timeframe: week 24
• Results posted on: 2013-05-27

Participant Flow

participants recruited from medical clinic, between 7/2008 and 6/2009and 20011

Overall sample size was reduced to 10 due to difficulty in recruitment

Participant milestones

Measure	Entecavir Intensification Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine	Standard of Care continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Entecavir Intensification for Persistent HBV Viremia in HIV-HBV Infection

Baseline characteristics by cohort

Measure	Entecavir Intensification n=5 Participants Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine	Standard of Care n=5 Participants continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants
HBV DNA at enrollment	3.2 log10 IU/ML n=5 Participants	3.8 log10 IU/ML n=7 Participants	3.2 log10 IU/ML n=5 Participants

PRIMARY outcome

Timeframe: week 24

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.

Outcome measures

Measure	Entecavir Intensification n=5 Participants Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine	Standard of Care n=5 Participants continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
Hepatitis B Virus (HBV) DNA	2.4 log 10 IU/ml Interval 0.8 to 2.41	0.8 log 10 IU/ml Interval 0.8 to 5.8

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Measure	Entecavir Intensification n=5 Participants Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine	Standard of Care n=5 Participants continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
Incidence of Permanent Discontinuation Due to Toxicity	0 participants	0 participants

SECONDARY outcome

Timeframe: every 4 weeks for 24 weeks

Outcome measures

Measure	Entecavir Intensification n=5 Participants Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine	Standard of Care n=5 Participants continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy)	0 participants	0 participants

SECONDARY outcome

Timeframe: every 4 weeks for 24 weeks

ALT flare: sudden increase in blood level of alanine transaminase (ALT)

Outcome measures

Measure	Entecavir Intensification n=5 Participants Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine	Standard of Care n=5 Participants continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
Incidence of ALT Flares	0 participants	0 participants

SECONDARY outcome

Timeframe: entry, week 12, and week 24

Outcome measures

Measure	Entecavir Intensification n=5 Participants Entecavir 1 mg for 24 weeks in addition to continued standard of care antiretroviral therapy containing tenofovir in addition to emtricitabine or lamivudine	Standard of Care n=5 Participants continued standard of care antiretroviral therapy which will include tenofovir in addition to emtricitabine or lamivudine
HIV RNA < 75 Copies/ml	5 participants	5 participants

Adverse Events

Entecavir Intensification

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anne Luetkemeyer

UCSF SFGH

Phone: 415 476 4082

Email: aluetkemeyer@php.ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place