Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1
Public ClinicalTrials.gov record NCT00784147. 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 Phase 2b, Randomized, Double-Blinded, 48-Week, Multicenter, Dose-Response Study of Ibalizumab Plus an Optimized Background Regimen in Treatment-Experienced Patients Infected With HIV-1(Amended to 24-Weeks)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The investigational product, ibalizumab, is a humanized IgG4 monoclonal antibody administered via intravenous infusion at 800 mg every 2 weeks or at 2000 mg every 4 weeks. In addition to study drug, all patients will receive an optimized background regimen (OBR), which is a standard-of-care regimen selected by the investigator prior to randomization that is comprised of 2-4 antiretroviral agents. These agents must have been approved by the local regulatory agency or be available through expanded-access programs for treatment of human immunodeficiency virus (HIV).
Study identification
- NCT ID
- NCT00784147
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 113 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- 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
- Aug 2008 (Type not available)
- Primary completion
- Apr 2011 (Actual)
- Completion
- Apr 2011 (Actual)
- Last update posted
- May 5, 2014
2008 – 2011
United States locations
- U.S. sites
- 28
- U.S. states
- 11
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AIDS Health Care Foundation - Research | Beverly Hills | California | 90211 | — |
| Living Hope Clinical Foundation | Long Beach | California | 90813 | — |
| Kaiser Permanente Medical Center | Los Angeles | California | 90027 | — |
| Quest Clinical Research | San Francisco | California | 94115 | — |
| Kaiser Permanente Medical Center Research Unit | San Francisco | California | 94118 | — |
| Kaiser Permanente of Colorado | Denver | Colorado | 80205 | — |
| National Jewish Medical & Research Center | Denver | Colorado | 80206 | — |
| Whitman-Walker Clinic | Washington D.C. | District of Columbia | 20009 | — |
| South Florida Clinical Research | Atlantis | Florida | 33462 | — |
| University of Miami, Miller School of Medicine | Miami | Florida | 33136 | — |
| Orlando Immunology Center | Orlando | Florida | 32802 | — |
| Associates in Infectious Diseases | Port Saint Lucie | Florida | 34952 | — |
| Treasure Coast Infectious Disease Consultants | Vero Beach | Florida | 32960 | — |
| Triple O Medical Services, Inc. | West Palm Beach | Florida | 33401 | — |
| Northstar Medical Center | Chicago | Illinois | 60657 | — |
| Indiana University School of Medicine - Wishard Memorial Hospital | Indianapolis | Indiana | 46202 | — |
| St. Michael's Medical Center | Newark | New Jersey | 07102 | — |
| AIDS Community Research Initiative of America | New York | New York | 10018 | — |
| The Brody School of Medicine at ECU | Greenville | North Carolina | 27834 | — |
| The Research & Educational Group | Portland | Oregon | 97210 | — |
| Central Texas Clinical Research | Austin | Texas | 78705 | — |
| North Texas Infectious Disease Consultants | Dallas | Texas | 75246 | — |
| Valley AIDS Council | Harlingen | Texas | 78550 | — |
| Therapeutic Concepts | Houston | Texas | 77004 | — |
| University of Texas Health Science Center | Houston | Texas | 77030 | — |
| Nationsmed Clinical Research | Houston | Texas | 77036 | — |
| Dr. Gordon E. Crofoot, MD, PA | Houston | Texas | 77098 | — |
| Research Access Network | Houston | Texas | 77098 | — |
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 NCT00784147, 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 May 5, 2014 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00784147 live on ClinicalTrials.gov.