Protease Inhibitor Vs. Raltegravir-based ART and Inflammation in HIV Infection

Inclusion criteria

• HIV-1 infected male or female adults greater than or equal to 18 years of age
• Participants who are on protease-inhibitor-based ART for more than a year
• Participants with any CD4 T-cell count.
• Participants with plasma viral load below level of detection (40 copies/mL)
• Able to understand and sign the informed consent form prior to screening
• Women of child-bearing potential must have a negative pregnancy test at screening and at Day 1 and agree to use the following approved methods of birth control while on study:

• Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide);
• Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion);
• Male partner sterilization confirmed prior to the female subject's entry into the study; this male is the sole partner for that subject;
• Approved hormonal contraception;
• Any other method with published data showing that the expected failure rate is <1% per year.

Any contraception method must be used consistently, in accordance with the approved product label, and for at least 2 weeks after discontinuation of metformin.

• Women of non-child-bearing potential as defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy.
• Men who are using at least one barrier method of contraception (e.g. condom).

Exclusion criteria

• Individuals with a known hypersensitivity/allergy to the Raltegravir.
• Individuals who are actively participating in an experimental therapy study or who have received experimental therapy within the last three months.
• Individuals who are suffering from severe systemic diseases (uncontrolled hypertension, chronic renal failure), or active uncontrolled infections
• Patients who are currently on any integrase inhibitor-based ART.
• Individuals with a history of congestive heart failure (NYHA I-IV) or individuals having a cardiac pacemaker
• Severe liver or kidney disease based on physician evaluation
• Elevated AST or ALT 3-fold above the upper normal limit
• Elevated alkaline phosphatase 2-fold above upper normal limit
• Elevated creatinine (above 150 µmol/l)
• Current use of oral steroids
• A systemic infection within the last month
• Women who are pregnant or breastfeeding.