Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV An… (NCT00782301) | Clinical Trial Compass
WithdrawnPhase 4
Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected Patients
United States, Canada, Poland0Started 2009-03
Plain-language summary
Confirm the safety of maraviroc when used as a component of combination antiretroviral therapy in HIV and Hepatitis co-infected patients.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.