HIV Infections Clinical Research Study

What is the purpose of this study?

Treatment of HIV with antiretroviral regimens that include protease inhibitors (PIs) frequently results in the suppression of HIV viral load, significant immune recovery, and delayed disease progression. However, treatment with PIs has been associated with significant increases in cholesterol and triglycerides in HIV infected adults and children. The purpose of this study is 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 antiretroviral regimens containing at least one PI.

Can I participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions: HIV Infections, Hyperlipidemia
• Age: Between 10 - 18 Years
• Gender: Male or Female
• +

  Inclusion Criteria:

  HIV infected

  CD4 count of at least 15 at screening

  Viral load of at least 10 000 copies/ml at screening

  Receiving stable antiretroviral therapy regimen containing at least one protease

  inhibitor for at least 6 months

  Tanner stage of 2 or higher

  Certain fasting LDL cholesterol values and cardiovascular risk factors/co-morbidities.

  More information on this criterion can be found in the protocol.

  Able to fast overnight for 8 hours

  Agree to use two appropriate forms of contraception. More information on this

  criterion can be found in the protocol.
• +

  Exclusion Criteria:

  Certain abnormal laboratory values

  Any laboratory or unresolved clinical toxicity equal to 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 study entry.

  Chemotherapy for malignancy within 3 months prio 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

Detail Study Description

Antiretroviral regimens containing PIs often cause hyperlipidemia, which is an increase in the amount of fat (such as cholesterol and triglycerides) in the blood. These increases can lead to heart disease and pancreatitis. Although the mechanism by which PIs cause hyperlipidemia is not clearly understood, there are medications to combat this side effect. The primary purpose of this study is to evaluate the safety and effectiveness of escalating doses of atorvastatin, based on low-density lipoprotein (LDL) cholesterol levels, in HIV-infected children receiving antiretroviral regimens containing at least one PI. This study will last no longer than 48 weeks. Participants will be assigned to one of two groups according to age. One group will include participants from ages 10 to 14 years with participants from ages 15 to 18 years in the other. The first six participants enrolled in the study will be from the 15 to 18 year old age group. Once safety data through Week 8 on these 6 participants has been analyzed, the remaining participants will be enrolled. All participants will receive atorvastatin in combination with a stable antiretroviral regimen including at least one PI. Each participant will be followed independently according to a dose escalation algorithm for atorvastatin. Participants will begin dosing at 10 mg daily. If efficacy criteria are not met, dosing will increase to no more than 20 mg daily. Atorvastatin will be provided by the study, but antiretrovirals will not. This study will consist of seven study visits after screening. Visits will occur at study entry and Weeks 4, 8, 12, 24, 36, and 48. A physical exam, medical history, and adherence questionnaire will occur at all study visits. Blood collection will occur at most visits. Urine collection will occur at some visits.

Study Treatments

Atorvastatin

Last Updated: January 2010