ANTIRETROVIRAL-SPARING CONCEPT: AN EXPLORATORY PHASE II, RANDOMIZED, SINGLE BLIND PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFECT OF THERAPEUTIC IMMUNIZATION ON THE QUANTITY OF HIV-SPECIFIC T CELL PRECURSORS DURING HIGHLY ACTIVE ANTIRETROVIRAL THERAPY FOLLOWED BY ANALYTICAL TREATMENT INTERRUPTION

INTERVENTION: Product Name: LC002 DermaVir Patch Pharmaceutical Form: Cutaneous solution Current Sponsor code: LC002 DermaVir Concentration unit: mg/g milligram(s)/gram Concentration type: equal Pharmaceutical form of the placebo: Cutaneous solution Route of administration of the placebo: Transdermal use CONDITION: HIV‐1infected patients ; MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection PRIMARY OUTCOME: Main Objective: To investigate whether HIV PHPC counts measured at week 9 during maximally suppressive HAART in HIV+ adults is higher in subjects receiving DermaVir Patches treatment than in Placebo subjects Primary end point(s): PHPC counts at study Week 9 during HAART Secondary Objective: To determine whether subjects on fully‐suppressive HAART who develop increases in HIV‐specific PHPC have lower HIV‐1 RNA during ATI (defined as the geometric mean of HIV‐1 RNA obtained at Week 16and Week 20) than subjects who do not increase PHPC To investigate whether HIV‐specific PHPC counts measured during maximally suppressive HAART correlate with a lower Viral Load Time Averaged Area Under the Curve (TA‐AUC) during ATI To determine if subjects who experience an increase in PHPC Gag p17 counts &#8805; 2,000 and/or PHPC total Gag counts &#8805; 5,000 prior to ATI are more likely to maintain HIV‐1 RNA levels a.) below 400 copies/mL b.) below 5,000 copies/mL c.) lower than prior to HAART treatment at 16 and 20 weeks of an ATI than subjects who have PHPC Gag p17 counts < 2,000 and/or PHPC total Gag counts < 5,000 prior to ATI INCLUSION CRITERIA: HIV‐1‐infected adults; Age: ≥18 years and <50 years Provide written informed consent On a non‐hydroxyurea based HAART for at least one year Pre‐HAART CD4 nadir > 250 cells/mm3 Pre‐HAART viral load > 5,000 copies/mL At least two viral load and two CD4 measurement for determination of nadir prior to HAART initiation Undetectable viral load (i.e., three or more determinations of < 50 copies/mL with no values of ≥ 50 copies/mL) for the six month period preceding the study CD4 T‐cell count >500 cells/mm3 for the six month period preceding the study Patient willing to comply with study regimen/Analytical Treatment Interruption Female study volunteers who are participating in sexual activity that could lead to pregnancy must agree to not become pregnant and use two methods of contraception, including at least one form of barrier contraception, while receiving DermaVir/Placebo and for 6 months after the last administration. Me