Studies Implemented by University of Florida Jacksonville
| Study Number | Study Title | Study Status | Study Restriction |
|---|---|---|---|
|
(11954) |
Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission: A Phase I/II Proof of Concept Study |
Enrolling |
US & Non-US |
|
(11903) |
Open-Label, Dose-Escalating, Phase I Study to Determine Safety and Pharmacokinetic Parameters of Subcutaneous (SC) VRC01 and VRC01LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants |
Enrolling |
US & Non-US |
|
(11891) |
A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Raltegravir in HIV-1 Exposed Infants at High Risk |
Enrolling |
US & Non-US |
|
(11790) |
Raltegravir Pharmacokinetics and Safety in Neonates |
Closed to Accrual |
United States |
|
(10850) |
A Phase I/II, Open-Label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Etravirine (ETR) in Antiretroviral Experienced HIV-1 Infected Infants and Children, Aged >= 2 Months to < 6 Years |
Closed to Accrual |
US & Non-US |
|
(10660) |
A Prospective Surveillance Study of Long Term Outcomes in HIV-infected Infants, Children and Adolescents |
Closed to Follow Up |
United States |
|
(10495) |
A Phase I/II, Multicenter, Open-Label, Noncomparative Study of the International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Group to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of Raltegravir (Isentress™, MK-0518) in HIV-1 Infected Children and Adolescents |
Closed to Follow Up |
US & Non-US |
|
(30070) |
Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents |
Pending |
United States |
|
(34150) |
Phase I/II Study of the Pharmacokinetics, Safety and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-infected Children and Adolescents |
Open to Accrual |
US & Non-US |
|
(30129) |
Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants |
Enrolling |
US & Non-US |
ACTG 381 (10104) |
Establishment and Maintenance of Long-Term Undetectable Plasma HIV-1 RNA: Correlation with Immunologic Reconstitution and Viral Dynamics |
Concluded |
Not Applicable |
ACTG 219C (10035) |
Pediatric Late Outcomes Protocol |
Participants Off Study and Primary Analysis Completed |
Not Applicable |
|
(10670) |
A Phase III Comparative Study of Three Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Sparing Antiretroviral Regimens for Treatment-Naive HIV-1-Infected Volunteers |
Participants Off Study and Primary Analysis Completed |
United States |
|
(10395) |
The Optimized Treatment that Includes or Omits NRTIs (OPTIONS) Trial: A Randomized Strategy Study for HIV-1-Infected Treatment-Experienced Subjects Using the cPSS to Select an Effective Regimen |
Participants Off Study and Primary Analysis Completed |
United States |
|
(10779) |
HAART Standard Version of the PROMISE Study: Promoting Maternal and Infant Survival Everywhere |
Closed to Follow Up |
US & Non-US |