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

HIV Infection Clinical Trial

Official title:

See Detailed Description.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363142
• Other study ID #: LEX106430
• Status: Completed
• Phase: Phase 3
• First received: August 11, 2006
• Last updated: October 21, 2010
• Start date: May 2006
• Est. completion date: June 2008

Study information

• Verified date: October 2010
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection
• Infection, Human Immunodeficiency Virus

Intervention

Drug:
• Half-boosted Fosamprenavir
Once daily, reduced dose ritonavir-boosted fosamprenavir
• Full Boosted Fosamprenavir
Full ritonavir-boosted fosamprenavir

Locations

Country	Name	City	State
Puerto Rico	GSK Investigational Site	Ponce
Puerto Rico	GSK Investigational Site	San Juan
United States	GSK Investigational Site	Akron	Ohio
United States	GSK Investigational Site	Allentown	Pennsylvania
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Beverly Hills	California
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Fort Myers	Florida
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Garden Grove	California
United States	GSK Investigational Site	Hampton	Virginia
United States	GSK Investigational Site	Harlingen	Texas
United States	GSK Investigational Site	Hillsborough	New Jersey
United States	GSK Investigational Site	Hollywood	Florida
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Lansing	Michigan
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Macon	Georgia
United States	GSK Investigational Site	Maywood	Illinois
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Newport Beach	California
United States	GSK Investigational Site	Oakland Park	Florida
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Sarasota	Florida
United States	GSK Investigational Site	Somers Point	New Jersey
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Springfield	Massachusetts
United States	GSK Investigational Site	Springfield	Massachusetts
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tarzana	California
United States	GSK Investigational Site	Valhalla	New York
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	West Hollywood	California
United States	GSK Investigational Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24	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.	Week 24	No
Secondary	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	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.	Week 24	No
Secondary	Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis	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.	Week 24	No
Secondary	Mean Change From Baseline of log10 Copies/mL Plasma HIV-1 RNA Levels at Week 24, Observed Analysis	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.	Baseline and Week 24	No
Secondary	Median Change From Baseline of CD4+ Cell Count at Week 24, Observed Analysis	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.	Baseline and Week 24	No
Secondary	Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24	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.	Baseline through Week 24	No
Secondary	Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24	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.	Baseline through Week 24	No
Secondary	Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24	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%.	Baseline and Week 24	No
Secondary	Percent Change From Baseline in Low Density Lipoprotein (LDL) at Week 24	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%.	Baseline and Week 24	No
Secondary	Number of Participants With Plasma HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline	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.	Baseline through Week 24	No
Secondary	Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24	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.	Weeks 12 and 24	No