Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive
| Status: | Terminated |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2011 |
| End Date: | July 2014 |
A Phase IIb Randomized, Controlled, Partially Blinded Clinical Trial to Investigate Safety, Efficacy and Dose-response of BMS-986001 in Treatment-naive HIV-1-infected Subjects, Followed by an Open-label Period on the Recommended Dose
The purpose of this study is to identify at least one dose of BMS-986001 which is safe, well
tolerated, and efficacious when combined with Efavirenz (EFV) + Lamivudine (3TC) for
treatment-naive Human Immunodeficiency Virus 1 (HIV-1) infected subjects
tolerated, and efficacious when combined with Efavirenz (EFV) + Lamivudine (3TC) for
treatment-naive Human Immunodeficiency Virus 1 (HIV-1) infected subjects
Double Blind through Week 24. Partially Blind (to subjects, caregivers, Investigators)
through Week 48.
through Week 48.
Inclusion Criteria:
- At least 18 years of age, (or minimum age as determined by local regulatory or as
legal requirements dictate, whichever is higher)
- Plasma HIV-1 RNA > 5000 copies/mL
- Antiretroviral treatment-naive; defined as no current or previous exposure to > 1
week of an antiretroviral drug
- CD4+ T-cell count > 200 cells/mm3
Exclusion Criteria:
- Resistance to any of the study medications [Tenofovir Disoproxil Fumarate(TDF),
Efavirenz (EFV), Lamivudine (3TC)] or to HIV Protease Inhibitors (PIs)
- Contraindications to any of the study drugs
We found this trial at
19
sites
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Jacobi Medical Center In 1955, the NYC Department of Hospitals opened a new, specialized care...
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Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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