At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter, Randomized, Non-comparative, Controlled Study of Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients With Long-term Viral Suppression
In Brief
A Phase 2 clinical trial evaluating DNA + HIV-rAd5 vaccine, ART intensification (raltegravir), and 1 other intervention for HIV Infection. Completed, enrolled 28 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
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