Clinical trial
Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency…
NCT00485264 · National Institute of Allergy and Infectious Diseases (NIAID), NIH · Completed
Key facts
| NCT number | NCT00485264 |
|---|---|
| Title | Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents |
| Official title | 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 Antiviral Activity of Raltegravir (Isentress, MK-0518) in HIV-1 Infected Children and… |
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID), NIH |
| Collaborators | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) NIH |
| Status | Completed |
| Phase | Phase 1/Phase 2 |
| Study type | Interventional |
| Conditions | HIV Infections |
| Intervention type | Drug |
| Interventions | Raltegravir poloxamer film coated tablet, Raltegravir chewable tablet, Raltegravir oral granules for suspension (20 mg/mL) |
| Enrollment | 153 |
| Start date | Sep 17, 2007 |
| Primary completion | Jun 3, 2013 |
| Completion | May 18, 2017 |
| First posted | Jun 12, 2007 |
| Last update posted | Nov 2, 2021 |
| Countries | Argentina, Botswana, Brazil, Puerto Rico, South Africa, United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- 1–9 Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: