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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
4 mg subcutaneous injection at weeks 8 (DNA prime), 12 (DNA prime), 16 (DNA prime), and 32 (HIV-rAd5)
raltegravir 400 mg PO BID for 56 weeks
maraviroc 150, 300, or 600 mg PO BID (depending on PK interactions with other medications) for 56 weeks
University of California San Francisco
San Francisco, California, United States
Northwestern University
Chicago, Illinois, United States
Cornell University
New York, New York, United States
Change From Baseline in HIV DNA in PBMCs at Week 56
Time frame: 56 weeks
Change From Baseline in HIV DNA in Rectal Tissue at Week 56
Time frame: Week 56
Change From Baseline in CD4+ T Cell Count at Week 56
Time frame: Week 56
HIV Specific T-cell Response to Env
HIV-specific immunity: Interferon gamma ELISpot response to Env (clades A) at week 36 (one month after rAd5 boosting)
Time frame: 36 weeks
Serious Adverse Events Attributed to Study Treatments
Grade 3 or 4 serious adverse events related to study treatments (raltegravir, maraviroc, or HIV-recombinant Ad5-based vaccine)
Time frame: 56 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.