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Immunologic Memory (Supp. of ATN 024)

NCT00142753 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2017-02-28

No results posted yet for this study

Summary

This is an exploratory, laboratory-based evaluation of cellular immune response to immunization with hepatitis B surface antigen in HIV-infected and HIV-uninfected adolescents. This is a substudy of ATN 024 and ATN 025. This substudy will compare cellular immune response in responders and nonresponders to immunization and also evaluate the relationship of these factors to the persistence of known correlates of serologic protection for the hepatitis B virus.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

Engerix B

Standard adult dose for A1; increased adult dose for A2. Doses at Entry, Weeks 4 and 24. Non-responders (\<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive Engerix-B increased adult dose at Week 48.

BIOLOGICAL

Twinrix for ATN 024

Standard adult dosage, taken at Entry, Weeks 4 and 24. Non-responders (\<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive Engerix-B increased adult dose at week 48.

BIOLOGICAL

Recombivax

Dosage at entry and week 24; non-responders ((\<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive 3rd dose of Recombivax during weeks 48-72.

BIOLOGICAL

Twinrix for ATN 025

Doses at Entry and Week 24. Non-responders (\<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive a dose of Recombivax during week 48-72.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Stephen Obaro, MBBS, PhD · ATN

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00142753 on ClinicalTrials.gov