Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents
Public ClinicalTrials.gov record NCT01302847. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents
Study identification
- NCT ID
- NCT01302847
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- NIH
- Enrollment
- 181 participants
Conditions and interventions
Conditions
Interventions
- DTG film-coated tablets Drug
- DTG granules for suspension Drug
- DTG dispersible tablets Drug
Drug
Eligibility (public fields only)
- Age range
- 4 Weeks to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 19, 2011
- Primary completion
- Jan 19, 2021
- Completion
- Oct 17, 2023
- Last update posted
- Dec 11, 2024
2011 – 2023
United States locations
- U.S. sites
- 17
- U.S. states
- 9
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program (Site ID: 4601) | La Jolla | California | 92093-0672 | — |
| Miller Children's Hosp. Long Beach CA NICHD CRS (Site ID: 5093) | Long Beach | California | 90806 | — |
| David Geffen School of Medicine at UCLA NICHD CRS (Site ID: 5112) | Los Angeles | California | 90095-1752 | — |
| Univ. of California San Francisco NICHD CRS (Site ID: 5091) | San Francisco | California | 94143 | — |
| Univ. of Colorado Denver NICHD CRS (Site ID: 5052) | Aurora | Colorado | 80045 | — |
| Howard Univ. Washington DC NICHD CRS (Site ID: 5044) | Washington D.C. | District of Columbia | 20060 | — |
| South Florida CDTC Ft Lauderdale NICHD CRS (Site ID: 5055) | Fort Lauderdale | Florida | 33316 | — |
| USF - Tampa NICHD CRS (Site ID: 5018) | Tampa | Florida | 33606 | — |
| Rush Univ. Cook County Hosp. Chicago NICHD CRS (Site ID: 5083) | Chicago | Illinois | 60612 | — |
| Lurie Children's Hospital of Chicago (LCH) CRS (Site ID: 4001) | Chicago | Illinois | 60614-3393 | — |
| Children's Hosp. of Boston NICHD CRS (Site ID: 5009) | Boston | Massachusetts | 02115 | — |
| Boston Medical Center Ped. HIV Program NICHD CRS (Site ID: 5011) | Boston | Massachusetts | 02118 | — |
| Metropolitan Hosp. NICHD CRS (Site ID: 5003) | New York | New York | 10029 | — |
| Bronx-Lebanon Hospital Center NICHD CRS (Site ID: 5114) | The Bronx | New York | 10457 | — |
| Jacobi Med. Ctr. Bronx NICHD CRS (Site ID: 5013) | The Bronx | New York | 10461 | — |
| DUMC Ped. CRS (Site ID: 4701) | Durham | North Carolina | 27710 | — |
| Seattle Children's Research Institute CRS (Site ID: 5017) | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01302847, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 11, 2024 · Synced Jul 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01302847 live on ClinicalTrials.gov.