Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT00663234
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
23 Years
Study:
NCT00663234
Study Brief:
Protocol Section:
NCT00663234