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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
HIV Infection; Infection, Human Immunodeficiency Virus	Drug: Half-boosted Fosamprenavir; Drug: Full Boosted Fosamprenavir	Phase 3

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)

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	211 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	See Detailed Description.
Study Start Date :	May 2006
Actual Primary Completion Date :	June 2008
Actual Study Completion Date :	June 2008

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24 [ Time Frame: 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.

Secondary Outcome Measures :

1. 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 ]
   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.
2. Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis [ Time Frame: Week 24 ]
   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.
3. Mean Change From Baseline of log10 Copies/mL Plasma HIV-1 RNA Levels at Week 24, Observed Analysis [ Time Frame: Baseline and Week 24 ]
   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.
4. Median Change From Baseline of CD4+ Cell Count at Week 24, Observed Analysis [ Time Frame: Baseline and Week 24 ]
   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.
5. Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24 [ Time Frame: Baseline 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.
6. 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 ]
   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.
7. Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24 [ Time Frame: Baseline and 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%.
8. Percent Change From Baseline in Low Density Lipoprotein (LDL) at Week 24 [ Time Frame: Baseline and 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%.
9. 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 ]
   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.
10. Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24 [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00363142 History of Changes
Other Study ID Numbers:	LEX106430
First Posted:	August 15, 2006
Results First Posted:	September 24, 2009
Last Update Posted:	November 5, 2010
Last Verified:	October 2010

Keywords provided by GlaxoSmithKline:

HIV-1 LEXIVA Ritonavir Once-daily

Additional relevant MeSH terms:

Infection; Communicable Diseases; HIV Infections; Immunologic Deficiency Syndromes; Acquired Immunodeficiency Syndrome; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immune System Diseases; Slow Virus Diseases	Ritonavir; Fosamprenavir; HIV Protease Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors