Trials / Completed
CompletedNCT02128828
Effect of Cenicriviroc on HIV Neurocognitive Impairment
H020: Single-Arm Open Label, Pilot Study of CCR5/CCR2 Inhibitor Cenicriviroc (CVC) for HIV Associated Neurocognitive Disorder (HAND)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University of Hawaii · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The study hypothesis is that cenicriviroc will improve cognition in HIV infected individuals with cognitive impairment. The investigators will study the effect of cenicriviroc on cognition in 24 subjects over a 24 week period.
Detailed description
HIV-associated neurocognitive disease (HAND), particularly in its milder form, is estimated to occur in greater than 30% of HIV infected individuals in the era of potent antiretroviral therapy. As even mild disease leads to functional consequences with decreased ability to live independently, HAND is of substantial public health concern. HIV-induced immune activation/inflammation of monocytes (MO) may be primarily responsible for the development of HAND. Cenicriviroc is a combined CCR5 and CCR2 chemokine co-receptor antagonist. The investigators hypothesize that dual CCR5 and CCR2 blockade with the use of CVC will lead to measurable reductions in MO activation and lead to cognitive improvement by decreasing HIV infection of MO and by interrupting the trafficking of such MO into the central nervous system. The investigators propose a single arm, 24-week trial of CVC in 24 subjects with HIV-1 infection suppressed on ART (plasma HIV RNA \< 50 copies/ml) for 1 year or more with mild to moderate cognitive impairment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cenicriviroc | cenicriviroc given once daily for 24 weeks; number of pills dependent on recommended modifications based on patient's other antiretroviral medications and certain other medications anticipated to interact with cenicriviroc |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
- First posted
- 2014-05-01
- Last updated
- 2020-08-20
- Results posted
- 2020-08-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02128828. Inclusion in this directory is not an endorsement.