A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00363142
First received: August 11, 2006
Last updated: October 21, 2010
Last verified: October 2010
  Purpose

This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen administered either twice-daily or once-daily.


Condition Intervention Phase
HIV Infection
Infection, Human Immunodeficiency Virus
Drug: Half-boosted Fosamprenavir
Drug: Full Boosted Fosamprenavir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Virologic failure was defined as two consecutive plasma HIV-1 RNA measures greater than 400 copies/milliliter (mL) separated by at least 2 to 4 week. The percentage of participants not meeting the virologic failure definition was estimated with stratification by the six randomization strata using Mantel-Haenszel weights and the missing/discontinuation equals failure (MD=F) analysis. Missing/discontinuation values were considered failures.


Secondary Outcome Measures:
  • Percentage of Participants With Plasma Human Immunodeficiency Virus, Type 1, Ribonucleic Acid (HIV-1 RNA) <400 Copies/mL at Week 24, Time to Loss of Virologic Response (TLOVR) Analysis [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. The percentage of participants with plasma HIV-1 RNA <400 copies/mL at Week 24 were determined by the TLOVR algorithm with stratification by the six randomization strata.

  • Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. The percentage of participants plasma with HIV-1 RNA <50 copies/mL at Week 24 were determined by the TLOVR algorithm with stratification by the six randomization strata.

  • Mean Change From Baseline of log10 Copies/mL Plasma HIV-1 RNA Levels at Week 24, Observed Analysis [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. Change from baseline was defined as plasma HIV-1 RNA level at Week 24 minus plasma HIV-1 RNA level at baseline.

  • Median Change From Baseline of CD4+ Cell Count at Week 24, Observed Analysis [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    A blood sample was drawn to determine the CD4+ cell count at week 24. Change from baseline was defined as CD4+ cell count at Week 24 minus CD4+ cell count at baseline.

  • Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24 [ Time Frame: Baseline through Week 24 ] [ Designated as safety issue: No ]
    The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event. Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  • Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 [ Time Frame: Baseline through Week 24 ] [ Designated as safety issue: No ]
    The number of participants who experienced any grades 2 to 4 adverse events was tabulated. Adverse events were graded based on the Division of Acquired Immunodeficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events.

  • Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    A blood sample was drawn to determine the cholesterol, HDL, triglycerides levels at Week 24. Percent change in total blood cholesterol, HDL, and triglycerides was defined as (lipid level at Week 24 minus level at baseline) divided by level at baseline x 100%.

  • Percent Change From Baseline in Low Density Lipoprotein (LDL) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    A blood sample was drawn to determine the LDL level at Week 24. Percent change in LDL was defined as (LDL level at Week 24 minus level at baseline) divided by level at baseline x 100%.

  • Number of Participants With Plasma HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline [ Time Frame: Baseline through Week 24 ] [ Designated as safety issue: No ]
    A blood sample was drawn for subjects failing to respond to therapy and the mutations present in the virus were identified. For each subject, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of virologic failure were tabulated by drug class.

  • Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24 [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
    Blood samples were drawn at weeks 12 and 24 to determine the plasma levels of APV and RTV. Concentration at the end of the dosing interval at steady state (Ctau) was presented.


Enrollment: 211
Study Start Date: May 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FPV/r200
Fosamprenavir/ritonavir (either 700/100mg BID or 1400/200mg QD)
Drug: Full Boosted Fosamprenavir
Full ritonavir-boosted fosamprenavir
Other Names:
  • Fosamprenavir
  • ritonavir
Experimental: FPV/r100
Fosamprenavir/ritonavir 1400/100mg QD
Drug: Half-boosted Fosamprenavir
Once daily, reduced dose ritonavir-boosted fosamprenavir

Detailed Description:

A Phase IIIB, randomized, open-label, parallel group, multi-center, non-inferiority, 24-week study to evaluate the safety, efficacy and tolerability of switching from a 200mg ritonavir-boosted regimen of LEXIVA (700mg/100mg BID or 1400mg/200mg QD) to a once-daily, 100mg ritonavir-boosted regimen of LEXIVA (1400mg/100mg QD)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Subjects with HIV-1 infection.
  • Are willing and able to understand and provide written consent prior to participation in this study.

Exclusion criteria:

  • Are pregnant or breastfeeding.
  • Have an active AIDS condition, pancreatitis, poor kidney function, or clinically relevant hepatitis.
  • Have certain medical conditions that may make participation unsafe.
  • Take medication that may interact with the study medication.
  • Have a history of allergy to any of the study drugs or any excipients therein.
  • Other inclusion/exclusion criteria to be evaluated by the physician.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363142

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85006
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72207
United States, California
GSK Investigational Site
Beverly Hills, California, United States, 90211
GSK Investigational Site
Fountain Valley, California, United States, 92708
GSK Investigational Site
Garden Grove, California, United States, 92845
GSK Investigational Site
Los Angeles, California, United States, 90022
GSK Investigational Site
Newport Beach, California, United States, 92663
GSK Investigational Site
Tarzana, California, United States, 91356
GSK Investigational Site
West Hollywood, California, United States, 90069
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80220
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20037
United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Fort Myers, Florida, United States, 33901
GSK Investigational Site
Hollywood, Florida, United States, 33020
GSK Investigational Site
Miami, Florida, United States, 33136
GSK Investigational Site
Oakland Park, Florida, United States, 33334
GSK Investigational Site
Orlando, Florida, United States, 32804
GSK Investigational Site
Sarasota, Florida, United States, 34243
GSK Investigational Site
Tampa, Florida, United States, 33614
GSK Investigational Site
West Palm Beach, Florida, United States, 33408
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30339
GSK Investigational Site
Macon, Georgia, United States, 31201
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60657
GSK Investigational Site
Chicago, Illinois, United States, 60613
GSK Investigational Site
Chicago, Illinois, United States, 60612
GSK Investigational Site
Maywood, Illinois, United States, 60153
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46280
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21229-5299
GSK Investigational Site
Baltimore, Maryland, United States, 21201
United States, Massachusetts
GSK Investigational Site
Springfield, Massachusetts, United States, 01107
GSK Investigational Site
Springfield, Massachusetts, United States, 01103
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48202
GSK Investigational Site
Lansing, Michigan, United States, 48910
United States, New Jersey
GSK Investigational Site
Hillsborough, New Jersey, United States, 08844
GSK Investigational Site
Somers Point, New Jersey, United States, 08244
United States, New York
GSK Investigational Site
New York, New York, United States, 10011
GSK Investigational Site
Valhalla, New York, United States, 10595
United States, Ohio
GSK Investigational Site
Akron, Ohio, United States, 44304
United States, Pennsylvania
GSK Investigational Site
Allentown, Pennsylvania, United States, 18102
United States, South Carolina
GSK Investigational Site
Columbia, South Carolina, United States, 29203
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Dallas, Texas, United States, 75204
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
Harlingen, Texas, United States, 78550
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
Houston, Texas, United States, 77027
United States, Virginia
GSK Investigational Site
Hampton, Virginia, United States, 23666
United States, Washington
GSK Investigational Site
Spokane, Washington, United States, 99204
Puerto Rico
GSK Investigational Site
Ponce, Puerto Rico, 00731
GSK Investigational Site
San Juan, Puerto Rico, 00909-1711
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00363142     History of Changes
Other Study ID Numbers: LEX106430
Study First Received: August 11, 2006
Results First Received: June 11, 2009
Last Updated: October 21, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
HIV-1 LEXIVA Ritonavir Once-daily

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Ritonavir
Fosamprenavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014