Comparison of Two Dosing Regimens of GW433908/Ritonavir Versus Lopinavir/Ritonavir for 48 Weeks in HIV Patients Who Have Taken Protease Inhibitors and Experienced Virological Failure
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, HIV Protease Inhibitors, Ritonavir, RNA, Viral, Anti-HIV Agents, Viral Load, ABT 378, VX-175
Eligibility Criteria
Inclusion Criteria Patients may be eligible for this study if they: Have a viral load of 1,000 or more copies/ml. Have taken protease inhibitors (PIs). Have taken PI drugs for at least 12 straight weeks and have had virologic failure on the PIs. Are now taking antiretroviral therapy. Are male or female and are at least 13 years old (or 18 if local requirement) and can provide consent from parent or guardian if under 18. Are females unable to have children or, if are able to have children, are not pregnant and agree to use approved birth control. Exclusion Criteria Patients will not be eligible for this study if they: Have taken APV or LPV for more than 1 week. Have taken tenofovir disoproxil fumarate (TDF) or adefovir. Have taken more than 2 PIs. Are unable to take 2 active RTIs, as specified by the study. Have an active CDC Category C disease. Have certain abnormal laboratory tests. Are pregnant or breast-feeding. Have a serious health problem (e.g., diabetes, heart problems, hepatitis) that might risk the safety of the patient. Have a history of significant kidney or bone disease. Are not able to take drugs by mouth and cannot absorb them. Have had pancreatitis or hepatitis within the previous 6 months. Have a drug allergy or other allergy which might cause a problem during the study. Have had radiation or chemotherapy within 28 days of taking the study drug, or expect to need these during the study. Have taken drugs that affect the immune system (corticosteroids, interleukins, interferons) or drugs with anti-HIV activity (hydroxyurea or foscarnet) within 28 days prior to taking the study drug. Have had any HIV vaccine within 3 months before taking the study drug. Have taken certain other drugs within 28 days prior to taking the study drug, or expect to need them during the study. Use alcohol or illicit drugs in a way that the doctor feels would interfere with the study. Are not able to take the study drugs. Have inadequate kidney function.
Sites / Locations
- Phoenix Body Positive
- Ocean View Internal Medicine
- Bisher Akil
- Tower ID Med Associates
- Orange Coast Med Group
- Pacific Horizons Med Group
- Denver Inf Disease Consultants
- Physicans Home Service
- IDC Research Initiative
- Bach and Godofsky
- Community Health Care
- Therafirst Med Ctr
- North Broward Hosp District / HIV Clinical Research
- Florida ID Group
- Discovery Alliance Inc
- West Florida Clinical Research Ctr
- Med College of Georgia
- Rush Med College / Dept of Infectious Diseases
- Boston Med Ctr / Evans - 556
- Abbott-Northwestern Hosp / Clinic 42
- Southampton Healthcare Inc
- South Jersey Infectious Diseases Inc
- ID Care Inc
- Garden State Infectious Diseases / E I P Kennedy Health Sys
- Gervais Frechette
- Duke Univ Med Ctr
- Summa Health System
- Fanno Creek Clinic
- Roger Williams Med Ctr
- Methodist Healthcare
- Joseph Gathe
- Virginia Commonwealth Univ