IMPAACT P1063: Safety and Effectiveness of Atorvastatin in HIV Infected Children and Adolescents With Hyperlipidemia

Stopped early · Phase 1/Phase 2

Conditions studied: HIV Infections, Hyperlipidemia

In brief

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.

Key facts

Study ID

NCT00663234

Run by

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

People needed

28

Starts

2009-08-01

Expected to finish

2014-12-01

Last updated by the study team

2016-04-06

Who can join

Age: 10 and older, up to 23. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Univ. of Colorado Denver NICHD CRS (5052) — Aurora, Colorado, United States
• Univ. of Miami Ped. Perinatal HIV/AIDS CRS (4201) — Miami, Florida, United States
• University of South Florida Tampa (5018) — Tampa, Florida, United States
• Chicago Children's CRS (4001) — Chicago, Illinois, United States
• Tulane University (5095) — New Orleans, Louisiana, United States
• Boston Medical Center Ped. HIV Program NICHD CRS (5011) — Boston, Massachusetts, United States
• New York University NY (5012) — New York, New York, United States
• Metropolitan Hospital (5003) — New York, New York, United States
• Bronx-Lebanon Hospital IMPAACT CRS (6901) — The Bronx, New York, United States
• St. Jude/UTHSC CRS (6501) — Memphis, Tennessee, United States
• Texas Children's Hosp. CRS (3801) — Houston, Texas, United States

Full record on ClinicalTrials.gov

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