Status:
COMPLETED
Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Conditions:
HIV Infection
Hepatitis B
Eligibility:
All Genders
12-24 years
Phase:
PHASE4
Brief Summary
Hepatitis B is a contagious virus that can damage a person's liver. It can be prevented by vaccination, but for many HIV-positive people, the vaccines do not help them achieve adequate protection agai...
Detailed Description
Suboptimal response to hepatitis B vaccination in HIV+ adults and children has been well documented in the literature. Given the importance of preventing hepatitis B virus (HBV) co-infection in HIV+ y...
Eligibility Criteria
Inclusion
- Documented HIV+
- Age 12 to \< 25 years
- History of no or one hepatitis B vaccination
- Not pregnant.
- Females engaging in sexual intercourse must be willing to practice an approved method of birth control throughout the completion of the vaccine phase of the study.
Exclusion
- History of \> 1 hepatitis B vaccination
- Serologic evidence of past or present hepatitis B infection: anti-hepatitis B surface antigen (HBsAg), HBs-Ag or anti- hepatitis B core antigen (HBcAg)
- Previous allergic reaction to hepatitis A or B vaccinations or to yeast, thimerosal or aluminum.
- Active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the pre-entry exam.
- Presence of any known grade \>= 3 clinical or laboratory toxicity at the time of pre-entry per toxicity tables.
- Anticipation of long-term corticosteroid therapy or within 3 months preceding study randomization. Use of non-steroidal, anti-inflammatory agents and inhaled or topical corticosteroids are allowed.
- Receipt of any restricted medicine listed in the protocol section 8.1.3 within 3 months preceding randomization.
- Receipt of immune globulin product or plasma product within 6 months preceding randomization
- Receipt of licensed blood product or transfusion or any licensed vaccine within 4 weeks preceding randomization.
- Known or suspected diseases of the immune system, other than HIV, or treatment for a malignancy within 3 months of randomization.
- Other serious, acute or chronic medical or surgical conditions must be approved by the protocol chair.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
371 Patients enrolled
Trial Details
Trial ID
NCT00106964
Start Date
January 1 2004
End Date
June 1 2009
Last Update
March 29 2017
Active Locations (11)
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1
Childrens Hosp of Los Angeles
Los Angeles, California, United States, 90054
2
University of California at San Francisco
San Francisco, California, United States, 94118
3
Children's Hosp Natinal Med Center
Washington D.C., District of Columbia, United States, 20010
4
Tulane Med Center
New Orleans, Louisiana, United States, 70112