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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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Confirm the safety of maraviroc when used as a component of combination antiretroviral therapy in HIV and Hepatitis co-infected patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maraviroc | Active Comparator |
| |
| Etravirine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maraviroc | Drug | maraviroc 150 mg. p.o. b.i.d., darunavir 600 mg. p.o. b.i.d., ritonavir 100 mg. p.o. b.i.d., raltegravir 400 mg. p.o. b.i.d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L through Week 48. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of HCV treated subjects with Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L through 96. | 48 weeks | |
| Time to development of Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L. |
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Inclusion Criteria:
HIV-1 RNA viral load of ≥1000 copies/mL at the screening visit. Detectable HCV RNA levels or Hepatitis B surface antigen (HBsAg) positive. Previous antiretroviral treatment experience with at least 2 antiretroviral drug classes for ≥3 months.
Documented resistance to an NNRTI as well as documented resistance to another antiretroviral agent.
CCR5 tropic virus detected by the TrofileTM assay.
Exclusion Criteria:
Suspected or documented active, untreated HIV-1 related Opportunistic Infection (OI) or other condition requiring acute therapy at the time of randomization (subjects on a stable (>1 month) secondary OI prophylaxis regimen are eligible for the study; subjects on a primary OI prophylaxis regimen of any duration are also eligible for the study).
Prior treatment with darunavir/ritonavir, raltegravir, or another integrase inhibitor, etravirine, maraviroc or another CCR5 inhibitor for more than 14 days at any time.
Subjects receiving treatment for chronic Hepatitis or the expected need to initiate HCV treatment within 48 weeks of randomization. (Subjects who were previously treated for Hepatitis C are eligible for the study).
AST and/or ALT greater than 5 times the upper limit of normal (ACTG Grade 3).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Clearwater | Florida | 33765 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| etravirine | Drug | etravirine 200 mg. p.o. b.i.d., darunavir 600 mg. p.o. b.i.d., ritonavir 100 mg. p.o. b.i.d., raltegravir 400 mg. p.o. b.i.d. |
|
| 96 weeks |
| Percentage of subjects with Hy's law abnormalities through Week 48. | 48 weeks |
| Percentage of HCV treated subjects with Hy's law abnormalities through Week 96. | 96 weeks |
| Change from baseline in mean Hepatitis C viral load through Week 48 | 48 weeks |
| Undetectable HCV viral load 24 weeks after stopping HCV treatment. | 240 weeks |
| Percentage of subjects with HIV-1 RNA levels <48 copies/mL at Week 48. | 48 weeks |
| Change from baseline in CD4+ cell count at Week 48. | 48 weeks |
| Change from baseline in mean hepatitis B DNA through Week 48 | 48 Weeks |
| Orlando |
| Florida |
| 32803 |
| United States |
| Pfizer Investigational Site | Safety Harbor | Florida | 34695 | United States |
| Pfizer Investigational Site | Wilton Manors | Florida | 33305 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30308 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30312 | United States |
| Pfizer Investigational Site | New Orleans | Louisiana | 70112 | United States |
| Pfizer Investigational Site | Worcester | Massachusetts | 01605 | United States |
| Pfizer Investigational Site | Worcester | Massachusetts | 01655 | United States |
| Pfizer Investigational Site | Mount Vernon | New York | 10550 | United States |
| Pfizer Investigational Site | Tulsa | Oklahoma | 74135 | United States |
| Pfizer Investigational Site | Bellaire | Texas | 77401 | United States |
| Pfizer Investigational Site | Conroe | Texas | 77301 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75390 | United States |
| Pfizer Investigational Site | Stafford | Texas | 77477 | United States |
| Pfizer Investigational Site | Vancouver | British Columbia | V6Z 2C7 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M5G 2N2 | Canada |
| Pfizer Investigational Site | Bydgoszcz | 85-030 | Poland |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000163 | Acquired Immunodeficiency Syndrome |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D015658 | HIV Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006526 | Hepatitis C |
| D018178 | Flaviviridae Infections |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| C451734 | etravirine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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