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Strategies for the Prevention of Hepatitis B Among HIV Infected Patients in Uganda

NCT02316444 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2019-01-25

No results posted yet for this study

Summary

The aim of this study is to compare the effectiveness of two vaccination strategies against Hepatitis B virus (HBV) in subjects already infected with human immunodeficiency virus (HIV).

Researchers plan to determine the optimal vaccination strategy for achieving protective immunity to HBV infection in HIV-infected adults attending Mulago Hospital's HIV care clinic.

Primary objectives are to assess:

1. The role of CD4-cell count and HIV viral loads on the HBV vaccine response.
2. The role of highly active antiretroviral therapy (HAART) on the HBV vaccine response.

The secondary objective is to evaluate whether lack of HAART is associated with high rates of loss to follow-up.

Conditions

  • HIV/AIDS and Infections

Interventions

BIOLOGICAL

Hepatitis B vaccine

An eligible participant will receive 3 doses of hepatitis B vaccine ( 20mcg in the deltoid intramuscular). Then their immune response will be assessed. Non responders will receive 3 additional vaccine doses off protocol

Sponsors & Collaborators

  • Makerere University

    collaborator OTHER

  • Uganda Cancer Institute

    collaborator OTHER

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Ponsiano Ocama, PhD · Makerere University

  • Corey Casper, MD · Fred Hutchinson Cancer Center

  • Emmanuel Seremba, MMED · HCRI-Ug, Makerere University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-04-28
Completion
2017-04-28

Countries

  • Uganda

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 NCT02316444 on ClinicalTrials.gov