Effects of Switching Efavirenz to Raltegravir on Vascular Function and Bone Markers in HIV-infected Patients

Inclusion Criteria

• HIV-1 infection, documented by (1) any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or (2) by two detectable HIV-1 antigens, or (3) two detectable plasma HIV-1 RNA viral loads.
• Age equal to or greater than 18 years.
• Receipt of TDF/FTC/EFV as the subject's initial ART regimen for at least one year prior to Screening.

Note: Interruptions in TDF/FTC/EFV of up to 10 days total during the 90 days prior to screening are allowed.

Note: Subjects who had received 3TC (lamivudine) with TDF/EFV as part of their initial regimen but have received TDF/FTC/EFV for at least one year prior to screening will be eligible.

• HIV-1 RNA level 3 times ULN at screening.
• Total bilirubin > 2.5 times ULN at screening.
• Fever, defined as T ≥ 38.0C within 48 hours prior to screening.

Note: Fever within 48 hours prior to each main study visit will require postponement of that study visit until the patient has defervesced (T 160mmHg or diastolic blood pressure > 100mgHg at screening.

• Receipt of investigational agents, cytotoxic chemotherapy, systemic glucocorticoids (of any dose), or anabolic steroids at screening.

Note: Physiologic testosterone replacement therapy is not exclusionary.

• Receipt of lipid-lowering drugs or anticonvulsants (defined as those drugs with significant CYP 450 induction or inhibition) screening.
• Use of sildenafil, vardenafil, or tadalafil within 72 hours (before or after) of each main study visit.
• Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.