HIV-1-infection Clinical Trial
Official title:
A Longitudinal Cohort Study to Assess Sustained Immunogenicity up to 48 Months to Quadrivalent Human Papillomavirus Vaccine Among HIV-infected Girls and Boys Age 10-15 Years in Kenya
NCT number | NCT04711265 |
Other study ID # | KENYAMRI |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | January 2019 |
Verified date | January 2021 |
Source | Kenya Medical Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Longitudinal observational cohort study and extension of the MISP ID: 38406 'immunogenicity and safety of quadrivalent human papillomavirus vaccine in HIV-infected pre-adolescent girls and boys in Kenya'.
Status | Completed |
Enrollment | 176 |
Est. completion date | January 2019 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 9 Years to 14 Years |
Eligibility | Inclusion Criteria: - receipt of 3 doses of QHPV vaccine - participated in primary immunogenicity study - consent/assent with parental consent for participants age <18 years - willing to continue extended follow up for 36 months Exclusion Criteria: - decline consent |
Country | Name | City | State |
---|---|---|---|
Kenya | Partners in Health Research and Development | Thika | Kiambu |
Lead Sponsor | Collaborator |
---|---|
Kenya Medical Research Institute | Merck Sharp & Dohme Corp., University of Washington |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Human Papillomavirus Antibody Titers | Geometric mean titers for HPV type -6, -11, -16 and -18 | 48 months | |
Secondary | HIV RNA viral load | Impact of HIV RNA viral load on HPV antibody response | 48 months | |
Secondary | CD 4 cell count | Impact of immune status on HPV antibody response | 48 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03940521 -
Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment
|
||
Completed |
NCT03227731 -
Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women
|
Phase 2/Phase 3 | |
Completed |
NCT03570918 -
MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy
|
Phase 1 | |
Not yet recruiting |
NCT06336434 -
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04022967 -
ANRS 12372 MODERATO Study
|
Phase 3 | |
Not yet recruiting |
NCT06282783 -
Studying Topiramate for Re-Activating the HIV-1 Reservoir
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06337032 -
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
|
Phase 4 | |
Recruiting |
NCT03536234 -
Efficacy and Safety of GnRH Analogue Triptorelin for HIV-1 Reservoir Reduction in ART Treated HIV-1 Infected Patients
|
Phase 2 | |
Completed |
NCT04340388 -
Contribution of Dolutegravir to Obesity and Cardiovascular Disease
|
Phase 4 | |
Withdrawn |
NCT05769569 -
Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission
|
Phase 1 | |
Enrolling by invitation |
NCT05584397 -
Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV on Tenofovir-containing Versus NRTI-free ART
|
||
Completed |
NCT04963712 -
Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder
|
Early Phase 1 | |
Not yet recruiting |
NCT04894357 -
Impact of V106I on Resistance to Doravirine
|
||
Completed |
NCT04388904 -
Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART)
|
Phase 4 | |
Not yet recruiting |
NCT04311944 -
Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD
|
N/A | |
Completed |
NCT04568239 -
Impact of M184V on the Virological Efficacy to 3TC/DTG (LAMRES)
|
||
Not yet recruiting |
NCT04311957 -
Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults
|
Phase 4 | |
Not yet recruiting |
NCT04513496 -
Telemedicine in HIV Care in Buenos Aires
|
||
Completed |
NCT03998176 -
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE
|
Phase 4 | |
Completed |
NCT04416906 -
A Test and Treat Strategy in New HIV Diagnosis.
|
Phase 3 |