Clinical trial NCT00025727: 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
Official title: A Phase III, Randomized, Multicenter, Parallel Group, Open-Label, Three Arm Study to Compare the Efficacy and Safety of Two Dosing Regimens of GW433908/Ritonavir (700mg/100mg Twice Daily or 1400mg/200mg Once Daily) Versus Lopinavir/Ritonavir (400mg/100mg Twice Daily) for 48 Weeks in Protease Inhibitor Experienced HIV-Infected Adults Experiencing Virological Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV-1
HIV Protease Inhibitors
Ritonavir
RNA, Viral
Anti-HIV Agents
Viral Load
ABT 378
VX-175
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-10-16
Enrollment: 330
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test 2 different dosing regimens of GW433908/ritonavir (RTV) versus lopinavir (LPV)/RTV when each is given with 2 active reverse transcriptase inhibitors (RTIs), in patients who have taken anti-HIV drugs without success.

Detailed description: Patients will receive 2 dosing regimens of GW433908/RTV or LPV/RTV, in combination with 2 active RTIs, after failing their first or second protease inhibitor-containing regimen. Patients are required to be on therapy at time of screening and must remain on this therapy until Day 1.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Body Positive
state: Arizona
city: Long Beach
country: United States
facility: Ocean View Internal Medicine
state: California
city: Los Angeles
country: United States
facility: Bisher Akil
state: California
city: Los Angeles
country: United States
facility: Tower ID Med Associates
state: California
city: Newport Beach
country: United States
facility: Orange Coast Med Group
state: California
city: San Francisco
country: United States
facility: Pacific Horizons Med Group
state: California
city: Denver
country: United States
facility: Denver Inf Disease Consultants
state: Colorado
city: Washington
country: United States
facility: Physicans Home Service
state: District of Columbia
city: Altamonte Springs
country: United States
facility: IDC Research Initiative
state: Florida
city: Bradenton
country: United States
facility: Bach and Godofsky
state: Florida
city: Fort Lauderdale
country: United States
facility: Community Health Care
state: Florida
city: Fort Lauderdale
country: United States
facility: Therafirst Med Ctr
state: Florida
city: Fort Lauderdale
country: United States
facility: North Broward Hosp District / HIV Clinical Research
state: Florida
city: Orlando
country: United States
facility: Florida ID Group
state: Florida
city: Pensacola
country: United States
facility: Discovery Alliance Inc
state: Florida
city: Pensacola
country: United States
facility: West Florida Clinical Research Ctr
state: Florida
city: Augusta
country: United States
facility: Med College of Georgia
state: Georgia
city: Chicago
country: United States
facility: Rush Med College / Dept of Infectious Diseases
state: Illinois
city: Boston
country: United States
facility: Boston Med Ctr / Evans - 556
state: Massachusetts
city: Minneapolis
country: United States
facility: Abbott-Northwestern Hosp / Clinic 42
state: Minnesota
city: St. Louis
country: United States
facility: Southampton Healthcare Inc
state: Missouri
city: Somers Point
country: United States
facility: South Jersey Infectious Diseases Inc
state: New Jersey
city: Somerville
country: United States
facility: ID Care Inc
state: New Jersey
city: Voorhees
country: United States
facility: Garden State Infectious Diseases / E I P Kennedy Health Sys
state: New Jersey
city: New York
country: United States
facility: Gervais Frechette
state: New York
city: Durham
country: United States
facility: Duke Univ Med Ctr
state: North Carolina
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Portland
country: United States
facility: Fanno Creek Clinic
state: Oregon
city: Providence
country: United States
facility: Roger Williams Med Ctr
state: Rhode Island
city: Memphis
country: United States
facility: Methodist Healthcare
state: Tennessee
city: Houston
country: United States
facility: Joseph Gathe
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth Univ
state: Virginia
Study officials:
References: