IMPAACT P1063: Safety and Effectiveness of Atorvastatin in HIV Infected Children and Adolescents With Hyperlipidemia
Public ClinicalTrials.gov record NCT00663234. 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.
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Official title
Phase I/II Safety and Efficacy Investigation of Atorvastatin for Treatment of PI-Associated Increased LDL Cholesterol in HIV-Infected Children and Adolescents
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Treatment of HIV with combination antiretroviral regimens frequently results in the suppression of HIV viral load, significant immune recovery, and delayed disease progression. However, treatment with these regimens, particularly protease inhibitors (PIs), has been associated with significant increases in cholesterol and triglycerides in HIV-infected adults and children. The purpose of this study was to evaluate the safety and effectiveness of escalating doses of atorvastatin, a FDA-approved drug which lowers cholesterol and triglyceride levels, in HIV-infected children receiving stable antiretroviral regimens.
Study identification
- NCT ID
- NCT00663234
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 28 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 10 Years to 23 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
- Aug 2009 (Type not available)
- Primary completion
- Dec 2014 (Actual)
- Completion
- Dec 2014 (Actual)
- Last update posted
- Apr 6, 2016
2009 – 2014
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ. of Colorado Denver NICHD CRS (5052) | Aurora | Colorado | 80045 | — |
| Univ. of Miami Ped. Perinatal HIV/AIDS CRS (4201) | Miami | Florida | 33136 | — |
| University of South Florida Tampa (5018) | Tampa | Florida | 33620 | — |
| Chicago Children's CRS (4001) | Chicago | Illinois | 60614 | — |
| Tulane University (5095) | New Orleans | Louisiana | 70112 | — |
| Boston Medical Center Ped. HIV Program NICHD CRS (5011) | Boston | Massachusetts | 02118 | — |
| New York University NY (5012) | New York | New York | 10016 | — |
| Metropolitan Hospital (5003) | New York | New York | 10029 | — |
| Bronx-Lebanon Hospital IMPAACT CRS (6901) | The Bronx | New York | 10457 | — |
| St. Jude/UTHSC CRS (6501) | Memphis | Tennessee | 38105 | — |
| Texas Children's Hosp. CRS (3801) | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00663234, 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 Apr 6, 2016 · Synced Nov 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00663234 live on ClinicalTrials.gov.