Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140
Public ClinicalTrials.gov record NCT02483078. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-center, Randomized, Double-blind, Placebo-controlled Trial, Followed by Single-arm Treatment of PRO 140 in Combination With Optimized Background Therapy in Treatment-Experienced HIV-1 Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 2b/3, multi-center, two part study, designed to evaluate the efficacy, safety, and tolerability of PRO 140 in conjunction with existing ART (failing regimen) for one week and Optimized Background Therapy (OBT) for 24 weeks respectively. Study population includes treatment-experienced HIV-infected patients with CCR5-tropic virus who demonstrates evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented genotypic or phenotypic resistance to ART drugs within three drug classes (or within two or more drug classes with limited treatment options).The options may be limited as a result of drug antiviral class cross-resistance or documented treatment intolerance.
Study identification
- NCT ID
- NCT02483078
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 52 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2015
- Primary completion
- Jan 31, 2018
- Completion
- Jun 30, 2018
- Last update posted
- Nov 2, 2022
2015 – 2018
United States locations
- U.S. sites
- 34
- U.S. states
- 13
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CD02 Investigational site | Fountain Valley | California | 92708 | — |
| CD02 Investigational site | Long Beach | California | 90813 | — |
| CD02 Investigational site | Los Angeles | California | 90008 | — |
| CD02 Investigational Site | Los Angeles | California | 90036 | — |
| CD02 Investigational site | Palm Springs | California | 92262 | — |
| CD02 Investigational Site | San Francisco | California | 94115 | — |
| CD02 Investigational site | San Francisco | California | 94118 | — |
| CD02 Investigational Site | New Haven | Connecticut | 06510 | — |
| CD02 Investigational site | Norwalk | Connecticut | 06850 | — |
| CD02 Investigational Site | Washington D.C. | District of Columbia | 20009 | — |
| CD02 Investigational site | Washington D.C. | District of Columbia | 20017 | — |
| CD02 Investigational Site | Clearwater | Florida | 33761 | — |
| CD02 Investigational site | Ft. Pierce | Florida | 34982 | — |
| CD02 Investigational site | Miami | Florida | 20852 | — |
| CD02 Investigational site | Miami | Florida | 33136 | — |
| CD02 Investigational Site | Miami | Florida | 33169 | — |
| CD02 Investigational site | Miami Beach | Florida | 33139 | — |
| CD02 Investigational site | Orlando | Florida | 32803 | — |
| CD02 Investigational site | West Palm Beach | Florida | 33401 | — |
| CD02 Investigational site | Chicago | Illinois | 60613 | — |
| CD02 Investigational site | Wichita | Kansas | 67214 | — |
| E Study Site | Las Vegas | Nevada | 89109 | — |
| CD02 Investigational site | New York | New York | 10001 | — |
| CD02 Investigational site | New York | New York | 10011 | — |
| CD02 Investigational site | Syracuse | New York | 13210 | — |
| CD02 Investigational site | Charlotte | North Carolina | 28226 | — |
| CD02 Investigational site | Cincinnati | Ohio | 45267 | — |
| CD02 Investigational Site | Austin | Texas | 78705 | — |
| CD02 Investigational Site | Bellaire | Texas | 77301 | — |
| CD02 Investigational site | Dallas | Texas | 75231 | — |
| CD02 Investigational Site | Houston | Texas | 77004 | — |
| CD02 Investigational site | Houston | Texas | 77098 | — |
| CD02 Investigational Site | Annandale | Virginia | 22003 | — |
| CD02 Investigational Site | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02483078, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 2, 2022 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02483078 live on ClinicalTrials.gov.