Trials / Withdrawn
WithdrawnNCT02257788
PRO 140 for Human Immunodeficiency Virus Infection
PRO 140 2103: A Phase 2a, Randomized Study of PRO 140 by Subcutaneous Injection in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Drexel University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
PRO 140 2103 is a multicenter, randomized parallel group study, conducted in male and female adult subjects infected with CCR5-tropic HIV-1.
Detailed description
Protocol PRO 140 2103 is a multicenter, randomized parallel group study, conducted in approximately 40 male and female adult subjects (n=10/treatment group) infected with CCR5-tropic HIV-1. Subjects will be randomized into one of four treatment groups. Blood samples for drug concentrations, PD variables, and efficacy variables will be obtained over a 59-day period following initiation of dosing. Safety will be monitored throughout the course of the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PRO 140 | Humanized monoclonal antibody to CCR5 |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2015-02-01
- Completion
- 2015-02-01
- First posted
- 2014-10-06
- Last updated
- 2017-03-09
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02257788. Inclusion in this directory is not an endorsement.