Integrase Inhibitor (MK-0518) Viral Decay

The trial is a prospective, double-blind, randomized, placebo-controlled study with two phases: phase I to 48 weeks and phase II to 96 weeks with the primary analysis at 48 weeks. HIV-infected individuals who are taking their first standard cART regimen for at least four years with complete viral suppression. Upon enrollment, he/she will be randomized to one of two arms: the MK-0518 arm or the control arm. As each participant reaches week 48, he/she will be unblinded and those in the MK-0518 arm will continue taking MK-0518. Based on the results of an interim analysis, the control arm will be rolled over to receive MK-0518 for 48 weeks. After the screening, baseline visits and week 4 safety visit, follow-up visits will occur every 8 weeks for both arms.

Inclusion criteria

• Participant must be HIV-1 infected
• Participant must be 18 years old
• Participant must be taking first standard cART with 2-3 NRTIs and 1-2 PIs or an NNRTI for at least four years (first cART regimen may include changes due to toxicity but not due to virologic failure).
• Participant must have a VL < 50 copies/ml (using the standard available methods of detection) during the entire time on standard cART except for initial fall of VL and a maximum of two non-consecutive blips of < 100 copies/ml that the study investigator deems to be not clinically significant
• Female participant must agree to use two methods of birth control or abstinence during the period of the study
• Participant has to have signed full informed consent

Exclusion criteria

• Participant who would have difficulty participating in a trial due to non-adherence or substance abuse
• Participant who has taken mono or dual antiretroviral therapy in the past
• Participant who has had a VL > 50 copies/ml on any antiretroviral regimen
• Participant with any of the following abnormal laboratory test results in screening:

• Hemoglobin < 100 g/L
• Neutrophil count < 750 cells/L
• Platelet count < 50,000 cells/L
• AST or ALT > 5X the upper limit of normal
• Creatinine > 250 mol/L
• Participant with a malignancy
• Participant with other significant underlying disease (non-HIV) that might impinge upon disease progression or death
• Participant with an active AIDS-defining illness in the past six months
• Participant who is pregnant