Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected Patients
This study has been withdrawn prior to enrollment.
Sponsor:
ViiV Healthcare
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00782301
First received: October 29, 2008
Last updated: January 18, 2012
Last verified: January 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Confirm the safety of maraviroc when used as a component of combination antiretroviral therapy in HIV and Hepatitis co-infected patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B Human Immunodeficiency Virus Hepatitis C, Chronic |
Drug: maraviroc Drug: etravirine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Open, Comparative Trial Of Maraviroc Versus Etravirine Each In Combination With Darunavir/Ritonavir And Raltegravir For The Treatment Of Antiretroviral-Experienced HIV-1 Subjects Co-Infected With Hepatitis C And/Or Hepatitis B |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Ritonavir
Darunavir
Etravirine
Maraviroc
Raltegravir
Hepatitis A Vaccines
U.S. FDA Resources
Further study details as provided by ViiV Healthcare:
Primary Outcome Measures:
- 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. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- Time to development of Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
- Percentage of subjects with Hy's law abnormalities through Week 48. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- Percentage of HCV treated subjects with Hy's law abnormalities through Week 96. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
- Change from baseline in mean Hepatitis C viral load through Week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Undetectable HCV viral load 24 weeks after stopping HCV treatment. [ Time Frame: 240 weeks ] [ Designated as safety issue: No ]
- Percentage of subjects with HIV-1 RNA levels <48 copies/mL at Week 48. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Change from baseline in CD4+ cell count at Week 48. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Change from baseline in mean hepatitis B DNA through Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | March 2009 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Maraviroc |
Drug: maraviroc
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.
Other Name: Selzentry
|
| Active Comparator: Etravirine |
Drug: etravirine
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.
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782301
Locations
| United States, Florida | |
| Pfizer Investigational Site | |
| Clearwater, Florida, United States, 33765 | |
| Pfizer Investigational Site | |
| Orlando, Florida, United States, 32803 | |
| Pfizer Investigational Site | |
| Safety Harbor, Florida, United States, 34695 | |
| Pfizer Investigational Site | |
| Wilton Manors, Florida, United States, 33305 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30308 | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30312 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Worcester, Massachusetts, United States, 01655 | |
| Pfizer Investigational Site | |
| Worcester, Massachusetts, United States, 01605 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Mt. Vernon, New York, United States, 10550 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | |
| Tulsa, Oklahoma, United States, 74135 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Bellaire, Texas, United States, 77401 | |
| Pfizer Investigational Site | |
| Conroe, Texas, United States, 77301 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75390 | |
| Pfizer Investigational Site | |
| Stafford, Texas, United States, 77477 | |
| Canada, British Columbia | |
| Pfizer Investigational Site | |
| Vancouver, British Columbia, Canada, V6Z 2C7 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M5G 2N2 | |
| Poland | |
| Pfizer Investigational Site | |
| Bydgoszcz, Poland, 85-030 | |
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | ViiV Healthcare |
| ClinicalTrials.gov Identifier: | NCT00782301 History of Changes |
| Other Study ID Numbers: | A4001080 |
| Study First Received: | October 29, 2008 |
| Last Updated: | January 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by ViiV Healthcare:
|
HIV and Hepatitis co-infection |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Hepatitis Hepatitis A Hepatitis B Hepatitis C Immunologic Deficiency Syndromes Hepatitis C, Chronic Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Hepadnaviridae Infections DNA Virus Infections Flaviviridae Infections Hepatitis, Chronic |
ClinicalTrials.gov processed this record on February 28, 2013
