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

NCT00363142 | Completed Phase 3 Results

• 1 other identifier: LEX106430
• Study Type: interventional
• Target: 211
• Locations: 2 countries
• Sites: 51

Brief 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.

Conditions

HIV Infection; Infection, Human Immunodeficiency Virus

Keywords

HIV-1 LEXIVA Ritonavir Once-daily

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• 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

  Week 24

• Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis

  Week 24

• Mean Change From Baseline of log10 Copies/mL Plasma HIV-1 RNA Levels at Week 24, Observed Analysis

  Baseline and Week 24

• Median Change From Baseline of CD4+ Cell Count at Week 24, Observed Analysis

  Baseline and Week 24

• Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24

  Baseline through Week 24

Study Arms (2)

FPV/r200

ACTIVE COMPARATOR

Fosamprenavir/ritonavir (either 700/100mg BID or 1400/200mg QD)

Drug: Full Boosted Fosamprenavir

FPV/r100

EXPERIMENTAL

Fosamprenavir/ritonavir 1400/100mg QD

Drug: Half-boosted Fosamprenavir

Interventions

Half-boosted Fosamprenavir DRUG

Once daily, reduced dose ritonavir-boosted fosamprenavir

FPV/r100

Full Boosted Fosamprenavir DRUG

Full ritonavir-boosted fosamprenavir

Also known as: Fosamprenavir, ritonavir

FPV/r200

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (51)

GSK Investigational Site

Phoenix, Arizona, 85006, United States

Location

GSK Investigational Site

Little Rock, Arkansas, 72207, United States

Location

GSK Investigational Site

Beverly Hills, California, 90211, United States

Location

GSK Investigational Site

Fountain Valley, California, 92708, United States

Location

GSK Investigational Site

Garden Grove, California, 92845, United States

Location

GSK Investigational Site

Los Angeles, California, 90022, United States

Location

GSK Investigational Site

Newport Beach, California, 92663, United States

Location

GSK Investigational Site

Tarzana, California, 91356, United States

Location

GSK Investigational Site

West Hollywood, California, 90069, United States

Location

GSK Investigational Site

Denver, Colorado, 80220, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20037, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33316, United States

Location

GSK Investigational Site

Fort Myers, Florida, 33901, United States

Location

GSK Investigational Site

Hollywood, Florida, 33020, United States

Location

GSK Investigational Site

Miami, Florida, 33136, United States

Location

GSK Investigational Site

Oakland Park, Florida, 33334, United States

Location

GSK Investigational Site

Orlando, Florida, 32804, United States

Location

GSK Investigational Site

Sarasota, Florida, 34243, United States

Location

GSK Investigational Site

Tampa, Florida, 33614, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33408, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30339, United States

Location

GSK Investigational Site

Macon, Georgia, 31201, United States

Location

GSK Investigational Site

Chicago, Illinois, 60612, United States

Location

GSK Investigational Site

Chicago, Illinois, 60613, United States

Location

GSK Investigational Site

Chicago, Illinois, 60657, United States

Location

GSK Investigational Site

Maywood, Illinois, 60153, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46280, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21201, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21229-5299, United States

Location

GSK Investigational Site

Springfield, Massachusetts, 01103, United States

Location

GSK Investigational Site

Springfield, Massachusetts, 01107, United States

Location

GSK Investigational Site

Detroit, Michigan, 48202, United States

Location

GSK Investigational Site

Lansing, Michigan, 48910, United States

Location

GSK Investigational Site

Hillsborough, New Jersey, 08844, United States

Location

GSK Investigational Site

Somers Point, New Jersey, 08244, United States

Location

GSK Investigational Site

New York, New York, 10011, United States

Location

GSK Investigational Site

Valhalla, New York, 10595, United States

Location

GSK Investigational Site

Akron, Ohio, 44304, United States

Location

GSK Investigational Site

Allentown, Pennsylvania, 18102, United States

Location

GSK Investigational Site

Columbia, South Carolina, 29203, United States

Location

GSK Investigational Site

Dallas, Texas, 75204, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76104, United States

Location

GSK Investigational Site

Harlingen, Texas, 78550, United States

Location

GSK Investigational Site

Houston, Texas, 77027, United States

Location

GSK Investigational Site

Houston, Texas, 77030, United States

Location

GSK Investigational Site

Hampton, Virginia, 23666, United States

Location

GSK Investigational Site

Spokane, Washington, 99204, United States

Location

GSK Investigational Site

Ponce, 00731, Puerto Rico

Location

GSK Investigational Site

San Juan, 00909-1711, Puerto Rico

Location

Related Publications (1)

• Cohen C, Dejesus E, Lamarca A, Young B, Yau L, Patel L, Vavro C, Wire MB, Wannamaker P, Shaefer M. Similar virologic and immunologic efficacy with fosamprenavir boosted with 100 mg or 200 mg of ritonavir in HIV-infected patients: results of the LESS trial. HIV Clin Trials. 2010 Sep-Oct;11(5):239-47. doi: 10.1310/hct1105-239.

  PMID: 21126954 DERIVED

MeSH Terms

Conditions

HIV Infections; Infections; Acquired Immunodeficiency Syndrome

Interventions

fosamprenavir; Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 11, 2006
• First Posted: August 15, 2006
• Study Start: May 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: November 5, 2010
• Results First Posted: September 24, 2009

Record last verified: 2010-10

Locations

PR (2); US (49)