Conditions: HIV Infection
Keywords: HIV-1 infection Treatment intensification Immunomodulation HIV-rAd5 vaccine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 28
Healthy volunteers: no

Brief summary:
The objective of this study is to discover a new approach in which human immunodeficiency virus (HIV) can be eradicated from an infected individual by intensified antiretroviral treatment coupled with immunomodulation. The hypothesis is that eradication is possible only if very potent antiretroviral drugs are delivered in conjunction with an immunomodulatory agent that simultaneously attack the viral reservoirs.

Detailed description:
The objective of this study is to measure the impact of immunomodulation plus treatment intensification on the HIV reservoir in HIV-infected patients who have viral suppression on combination antiretroviral therapy. Treatment regimens first will be intensified by the addition of raltegravir and maraviroc for 8 week followed by immunomodulation with the NIH HIV-rAd5 vaccine plus DNA prime-boost for 24 weeks. The primary endpoint is measurement of change in peripheral cellular HIV DNA. A decrease of 0.5 log is considered significant. A secondary endpoints include change in HIV DNA in the rectal mucosa, immunologic changes in the peripheral blood and safety.

Arms:
arm 1: ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks) arm 2: ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)

Interventions: intervention 1: DNA + HIV-rAd5 vaccine intervention 2: ART intensification (raltegravir) intervention 3: ART intensification (maraviroc)
Intervention descriptions: intervention 1: 4 mg subcutaneous injection at weeks 8 (DNA prime), 12 (DNA prime), 16 (DNA prime), and 32 (HIV-rAd5) intervention 2: raltegravir 400 mg PO BID for 56 weeks intervention 3: maraviroc 150, 300, or 600 mg PO BID (depending on PK interactions with other medications) for 56 weeks

Protocol document: