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

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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