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NCT01302847 · ClinicalTrials.gov registry record · Phase 1
Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents
A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 181
- Enrollment target
- 20
- Study locations
NCT01302847: Completed Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01302847 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 181 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01302847, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 181 participants
- Enrollment target
- 20
- Study locations
Study Summary
Dolutegravir (DTG) is an HIV drug in the integrase inhibitor drug class. This study evaluated the pharmacokinetics (PK), safety, tolerability of and immune response to DTG when used concurrently with optimized background therapy (OBT) in HIV-1 infected infants, children, and adolescents.
Primary Outcome
All grade 3 or higher signs/symptoms, diagnoses, and laboratory AEs were included. AE grading was based on DAIDS AE Grading Table, Version 1.0, December 2004 (Clarification, August 2009). A 2-sided 95% Confidence Interval (CI) was calculated for the percentage using the binominal exact method.
Conditions Studied
Interventions
- DRUG DTG film-coated tablets
- DRUG DTG granules for suspension
- DRUG DTG dispersible tablets
Study Locations (20)
California
- University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program (Site ID: 4601) - La Jolla
- Miller Children's Hosp. Long Beach CA NICHD CRS (Site ID: 5093) - Long Beach
- David Geffen School of Medicine at UCLA NICHD CRS (Site ID: 5112) - Los Angeles
- Univ. of California San Francisco NICHD CRS (Site ID: 5091) - San Francisco
New York
- Metropolitan Hosp. NICHD CRS (Site ID: 5003) - New York
- Bronx-Lebanon Hospital Center NICHD CRS (Site ID: 5114) - The Bronx
- Jacobi Med. Ctr. Bronx NICHD CRS (Site ID: 5013) - The Bronx
Florida
- South Florida CDTC Ft Lauderdale NICHD CRS (Site ID: 5055) - Fort Lauderdale
- USF - Tampa NICHD CRS (Site ID: 5018) - Tampa
Illinois
- Rush Univ. Cook County Hosp. Chicago NICHD CRS (Site ID: 5083) - Chicago
- Lurie Children's Hospital of Chicago (LCH) CRS (Site ID: 4001) - Chicago
Massachusetts
- Children's Hosp. of Boston NICHD CRS (Site ID: 5009) - Boston
- Boston Medical Center Ped. HIV Program NICHD CRS (Site ID: 5011) - Boston
Colorado
- Univ. of Colorado Denver NICHD CRS (Site ID: 5052) - Aurora
District of Columbia
- Howard Univ. Washington DC NICHD CRS (Site ID: 5044) - Washington D.C.
North Carolina
- DUMC Ped. CRS (Site ID: 4701) - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2011-04-20 |
| Est. Completion | 2023-10-18 |
| Phase | Phase 1 |
What the finished NCT01302847 record still lists
NCT01302847 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (59% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which DTG film-coated tablets is the first listed.
NCT01302847 names 20 study sites across 12 states, led by California, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT01302847 about?
NCT01302847 is a clinical study titled "Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents". Dolutegravir (DTG) is an HIV drug in the integrase inhibitor drug class. This study evaluated the pharmacokinetics (PK), safety, tolerability of and immune response to DTG when used concurrently with optimized background therapy (OBT) in HIV-1 infected infants, children, and adolescents.
What is the current status of trial NCT01302847?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 181 participants. The study started on 2011-04-20. Estimated completion is 2023-10-18.
What conditions does trial NCT01302847 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT01302847?
The interventions under investigation include: DTG film-coated tablets (DRUG), DTG granules for suspension (DRUG), DTG dispersible tablets (DRUG).
Who is sponsoring clinical trial NCT01302847?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01302847 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01302847's enrollment target sits among peer trials
181 188th of 542 higher than 355 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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