Status:
TERMINATED
IMPAACT P1063: Safety and Effectiveness of Atorvastatin in HIV Infected Children and Adolescents With Hyperlipidemia
Lead Sponsor:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Hyperlipidemia
Eligibility:
All Genders
10-23 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
Antiretroviral regimens, particularly those containing PIs, often cause hyperlipidemia, which is an increase in the amount of fat (such as cholesterol and triglycerides) in the blood. These increases ...
Eligibility Criteria
Inclusion
- A diagnosis of HIV-1 infection
- CD4 % of at least 15 at screening
- HIV-1 viral load of less than 10,000 copies/ml at screening
- On a stable antiretroviral therapy regimen for at least 6 months
- Tanner stage of 2 or higher
- At least two LDL-C measurements of 130 mg/dL or higher over the 6 months prior to screening and after documented attempts at modifying diet and other risk factors. More information on this criterion can be found in the protocol.
- Able to fast overnight for 8 hours
- Negative pregnancy test at screening
- Agree to use two appropriate forms of contraception (female participants). More information on this criterion can be found in the protocol.
Exclusion
- Certain abnormal laboratory values
- Any laboratory or unresolved clinical toxicity of Grade 3 or higher
- Unlikely to remain on current antiretroviral therapy for at least six months after study entry
- Use of statin, fibrate, or niacin within 3 months prior to study entry
- Evidence of chronic ongoing myositis or history of myopathy or neuromuscular disorder
- Symptomatic peripheral neuropathy within 6 months prior to study entry
- Pharmacologic treatment for depression or other mental disorder excluding Attention Deficit Disorder within 30 days prior to study entry
- Presence of an active CDC Stage C opportunistic infection or serious bacterial infection requiring therapy within 2 weeks prior to screening.
- Chemotherapy for malignancy within 3 months prior to study entry
- Hepatitis B Surface Antigen positive
- Hepatitis C viremia
- Insulin-dependent diabetes mellitus
- Required treatment with an agent contraindicated with either atorvastatin or PIs. More information on this criterion can be found in the protocol.
- Pregnant or breastfeeding
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00663234
Start Date
August 1 2009
End Date
December 1 2014
Last Update
April 6 2016
Active Locations (11)
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1
Univ. of Colorado Denver NICHD CRS (5052)
Aurora, Colorado, United States, 80045
2
Univ. of Miami Ped. Perinatal HIV/AIDS CRS (4201)
Miami, Florida, United States, 33136
3
University of South Florida Tampa (5018)
Tampa, Florida, United States, 33620
4
Chicago Children's CRS (4001)
Chicago, Illinois, United States, 60614