HIV/AIDS and Infections Clinical Trial
Official title:
Strategies for the Prevention of Hepatitis B Viral Infection Among HIV Infected Adults in Uganda
NCT number | NCT02316444 |
Other study ID # | U010 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | November 2015 |
Est. completion date | April 28, 2017 |
Verified date | January 2019 |
Source | Fred Hutchinson Cancer Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 132 |
Est. completion date | April 28, 2017 |
Est. primary completion date | April 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Hepatitis B core antibody (anti-HBc) and anti-HBs negative 2. Age =18 years 3. HIV infected persons (HAART naïve and HAART exposed). HAART enrollees will be considered to be HAART exposed if they have been taking these medications for at least 3 months. Participants that have never been on HAART and those that have been on HAART for <3months will be considered to be HAART naïve. HAART exposed enrollees will have an adherence of at least 95%. 4. Ambulatory 5. Intention to attend the Mulago HIV/AIDS clinic for the 18 months 6. Able and willing to comply with study protocol including providing informed consent Exclusion Criteria: 1. History of hypersensitivity to vaccines or intolerance to any of the HBV vaccine components 2. Previously-confirmed diagnosis of decompensated liver disease or HCC 3. Serological evidence of prior receipt of the HBV vaccine (anti-HBS positive, anti-HBc negative) or documented (clinical) evidence of having been vaccinated. 4. Known history of HBV infection (HBsAg and/or anti-HBc positive). 5. Inability to follow study procedures 6. If a participant chooses not to consent to the review of his or her medical records |
Country | Name | City | State |
---|---|---|---|
Uganda | Mulago National referral hospital | Kampala |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Research Center | Makerere University, Uganda Cancer Institute |
Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hepatitis B virus (HBV) vaccine response | Measure Hepatitis B surface antibody (anti-HBs) levels and cell mediated immune response. | 18 months | |
Secondary | Loss to follow-up (HAART naive vs. HAART exposed individuals) | Compare the number of individuals lost to follow-up among the HAART naive and HAART exposed. | 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03063385 -
Puerto Rico Cuidalos Parent-adolescent Program
|
N/A | |
Active, not recruiting |
NCT04283929 -
Evaluation of Clinical Impacts and Costs of eHealth in Rwanda
|
N/A | |
Withdrawn |
NCT03938077 -
A Community-University Approach to Preventing HIV
|
N/A | |
Recruiting |
NCT04319367 -
A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs).
|
Phase 2 | |
Completed |
NCT03368456 -
Preventing HIV/STI in Urban Adolescents Via an mHealth Primary Care Intervention
|
N/A | |
Recruiting |
NCT04135443 -
Evaluation of 3T, a Sex-Positive HIV/STI Mobile App Intervention for Young Black Men Ages 14-19 Attracted to Men
|
N/A | |
Completed |
NCT03404297 -
Compression Therapy for Leg Ulcers and Kaposi Sarcoma in Western Kenya
|
N/A | |
Completed |
NCT03198663 -
POSSE Project: A Community-Level Intervention for Black YMSM
|
N/A | |
Completed |
NCT03445351 -
Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS
|
N/A | |
Completed |
NCT03252483 -
Integrating HIV and Hepatitis C Screening in an Urban Emergency Department
|
N/A | |
Completed |
NCT02712801 -
Antiretroviral Regime for Viral Eradication in Newborns
|
Phase 4 | |
Completed |
NCT02406482 -
Evaluating a Microfinance Intervention for Vulnerable Women in Kazakhstan
|
N/A | |
Recruiting |
NCT04788784 -
Patient-Reported Outcomes HIV BItherapy
|
||
Recruiting |
NCT05300035 -
Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control
|
Phase 2 |