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| Sponsor: | Pfizer |
|---|---|
| Information provided by (Responsible Party): | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00824369 |
Purpose
The purpose of the protocol is to assess long-term safety and tolerability of subjects who discontinue for any reason from UK-453,061 qualifying studies.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-1 |
Other: Standard of care tests if needed Drug: Standard of care tests if needed |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | A Phase 2b Open-Label Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1 Infected Subjects |
| Estimated Enrollment: | 330 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | August 2017 |
| Estimated Primary Completion Date: | August 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1. UK-453,061 500 mg QD
UK-453,061 500 mg QD+Tenofovir DF 300 mg/emtricitabine 200 mg QD
|
Other: Standard of care tests if needed
Some patients may have tests that are considered part of standard of care if they have not been performed within 3 months of the study visits.
|
|
Experimental: 2. UK-453,061 750 mg QD
UK-453,061 750 mg QD +Tenofovir DF 300 mg/emtricitabine 200 mg QD
|
Other: Standard of care tests if needed
Some patients may have tests that are considered part of standard of care if they have not been performed within 3 months of the study visits.
|
|
Experimental: 3. Efavirenz 600 mg QD
Efavirenz 600 mg QD +Tenofovir DF 300 mg/emtricitabine 200 mg QD
|
Other: Standard of care tests if needed
Some patients may have tests that are considered part of standard of care if they have not been performed within 3 months of the study visits.
|
|
Experimental: 4. UK-453,061 750 mg QD
UK-453,061 750 mg QD +1 optimized NRTI + Darunavir/ritonavir 600/100 mg BID
|
Other: Standard of care tests if needed
Some patients may have tests that are considered part of standard of care if they have not been performed within 3 months of the study visits.
|
|
Experimental: 5. UK-453,061 1000 mg QD
UK-453,061 750 mg QD +1 optimized NRTI + Darunavir/ritonavir 600/100 mg BID
|
Other: Standard of care tests if needed
Some patients may have tests that are considered part of standard of care if they have not been performed within 3 months of the study visits.
|
|
Experimental: 6. Etravirine 200 mg BID
Etravirine 200 mg BID+1 optimized NRTI + Darunavir/ritonavir 600/100 mg BID
|
Drug: Standard of care tests if needed
Some patients may have tests that are considered part of standard of care if they have not been performed within 3 months of the study visits.
|
To assess long term safety and tolerability of subjects who discontinue for any reason from UK-453,061 studies. The study will also assess efficacy of the subsequent regimens in these patients.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Show 33 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00824369 History of Changes |
| Other Study ID Numbers: | A5271038 |
| Study First Received: | January 15, 2009 |
| Last Updated: | January 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Rollover Safety |
Tolerability HIV Infections treatment experienced |
