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NCT00663234 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00663234
Other study ID # IMPAACT P1063
Secondary ID U01AI06863210167
Status Completed
Phase Phase 1/Phase 2
First received April 21, 2008
Last updated March 23, 2015
Start date August 2009
Est. completion date December 2014

Study information
Verified date March 2014
Source International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 18 Years
Eligibility Inclusion Criteria:

- HIV infected

- CD4 count of at least 15 at screening

- Viral load of less than 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.

Locations
Country Name City State
Puerto Rico San Juan City Hosp. PR NICHD CRS (5031) San Juan
Puerto Rico University of Puerto Rico Pediatric HIV/AIDS Research (6601) San Juan
United States Univ. of Colorado Denver NICHD CRS (5052) Aurora Colorado
United States Johns Hopkins University NICHD CRS (5092) Baltimore Maryland
United States University of Maryland NICHD CRS (5094) Baltimore Maryland
United States Univ. of Alabama Birmingham NICHD CRS (5096) Birmingham Alabama
United States Boston Medical Center Ped. HIV Program NICHD CRS (5011) Boston Massachusetts
United States Children's Hospital of Boston NICHD CRS (5009) Boston Massachusetts
United States Bronx-Lebanon Hospital IMPAACT CRS (6901) Bronx New York
United States Jacobi Medical Center Bronx (5013) Bronx New York
United States Chicago Children's CRS (4001) Chicago Illinois
United States Rush University Cook County Hospital NICHD CRS (5083) Chicago Illinois
United States Hutzel Hospital NICHD CRS (5089) Detroit Michigan
United States Wayne State University/Children's Hospital of Michigan NICHD CRS (5041) Detroit Michigan
United States Duke University Medical Center (DUMC) Pediatric CRS (4701) Durham North Carolina
United States South Florida CDC Ft Lauderdale NICHD CRS (5055) Ft Lauderdal Florida
United States Texas Children's Hosp. CRS (3801) Houston Texas
United States Univ. of Florida Jacksonville NICHD CRS (5051) Jacksonville Florida
United States Miller Children's Hospital Long Beach (5093) Long Beach California
United States Childrens Hospital Los Angeles NICHD CRS (5090) Los Angeles California
United States UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601) Los Angeles California
United States Usc La Nichd Crs (5048) Los Angeles California
United States St. Jude/UTHSC CRS (6501) Memphis Tennessee
United States Univ. of Miami Ped. Perinatal HIV/AIDS CRS (4201) Miami Florida
United States Tulane University (5095) New Orleans Louisiana
United States Columbia IMPAACT CRS (4101) New York New York
United States Metropolitan Hospital (5003) New York New York
United States New York University NY (5012) New York New York
United States NJ Med School CRS (2802) Newark New Jersey
United States Childrens Hospital of Philadelphia (6701) Philadelphia Pennsylvania
United States Strong Memorial Hospital, University of Rochester NICHD CRS (5057) Rochester New York
United States UCSD Mother, Child & Adolescent HIV Program(4601) San Diego California
United States Univ. of California San Francisco NICHD CRS (5091) San Francisco California
United States Harborview Medical Center NICHD CRS (5027) Seattle Washington
United States Univ of Washington Children's Hospital Seattle (5017) Seattle Washington
United States University of Washington NICHD CRS (5029) Seattle Washington
United States SUNY Stony Brook NICHD CRS (5040) Stony Brook New York
United States University of South Florida Tampa (5018) Tampa Florida
United States Harbor (UCLA) Medical Center NICHD CRS (5045) Torrance California
United States Children's National Med. Ctr. Washington DC NICHD CRS (5015) Washington District of Columbia
United States Howard University Washington DC NICHD CRS (5044) Washington District of Columbia
United States Washington Hospital Center NICHD CRS (5023) Washington District of Columbia
United States WNE Maternal Pediatric Adolescent AIDS CRS (7301) Worcester Massachusetts

Sponsors (3)
Lead Sponsor Collaborator
International Maternal Pediatric Adolescent AIDS Clinical Trials Group Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (3)

Kamin D, Hadigan C. Hyperlipidemia in children with HIV infection: an emerging problem. Expert Rev Cardiovasc Ther. 2003 May;1(1):143-50. Review. — View Citation

Penzak SR, Chuck SK. Management of protease inhibitor-associated hyperlipidemia. Am J Cardiovasc Drugs. 2002;2(2):91-106. Review. — View Citation

Solórzano Santos F, Gochicoa Rangel LG, Palacios Saucedo G, Vázquez Rosales G, Miranda Novales MG. Hypertriglyceridemia and hypercholesterolemia in human immunodeficiency virus-1-infected children treated with protease inhibitors. Arch Med Res. 2006 Jan;37(1):129-32. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Occurence of Grade 3 or 4 toxicity Throughout study Yes
Primary Low density lipoprotein cholesterol levels Throughout study No
Secondary Atorvastatin pharmacokinetic parameters Throughout study No
Secondary Fasting lipids Throughout study No
Secondary Inflammatory markers for cardiac disease risk Throughout study No
Secondary Viral load Throughout study No
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