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HIV InfectionPhase 3NCT00363142

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

A Phase 3 study testing Half-boosted Fosamprenavir and Full Boosted Fosamprenavir in people with HIV Infection and Infection, Human Immunodeficiency Virus, run by GlaxoSmithKline at 51 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Half-boosted Fosamprenavir and Full Boosted Fosamprenavir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
211 participants
Where
51 sitesin 2 countries
Study dates
May 2006to Jun 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

51 sites in 2 countries.

51 sites in 2 countries

United States49 sites

  • GSK Investigational Site

    Akron, Ohio, 44304

  • GSK Investigational Site

    Allentown, Pennsylvania, 18102

  • GSK Investigational Site

    Atlanta, Georgia, 30339

  • GSK Investigational Site

    Baltimore, Maryland, 21201

  • GSK Investigational Site

    Baltimore, Maryland, 21229-5299

  • GSK Investigational Site

    Beverly Hills, California, 90211

  • GSK Investigational Site

    Chicago, Illinois, 60612

  • GSK Investigational Site

    Chicago, Illinois, 60613

  • GSK Investigational Site

    Chicago, Illinois, 60657

  • GSK Investigational Site

    Columbia, South Carolina, 29203

  • GSK Investigational Site

    Dallas, Texas, 75204

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Denver, Colorado, 80220

  • GSK Investigational Site

    Detroit, Michigan, 48202

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33308

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33316

  • GSK Investigational Site

    Fort Myers, Florida, 33901

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Fountain Valley, California, 92708

  • GSK Investigational Site

    Garden Grove, California, 92845

  • GSK Investigational Site

    Hampton, Virginia, 23666

  • GSK Investigational Site

    Harlingen, Texas, 78550

  • GSK Investigational Site

    Hillsborough, New Jersey, 08844

  • GSK Investigational Site

    Hollywood, Florida, 33020

  • GSK Investigational Site

    Houston, Texas, 77027

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Indianapolis, Indiana, 46280

  • GSK Investigational Site

    Lansing, Michigan, 48910

  • GSK Investigational Site

    Little Rock, Arkansas, 72207

  • GSK Investigational Site

    Los Angeles, California, 90022

  • GSK Investigational Site

    Macon, Georgia, 31201

  • GSK Investigational Site

    Maywood, Illinois, 60153

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    New York, New York, 10011

  • GSK Investigational Site

    Newport Beach, California, 92663

  • GSK Investigational Site

    Oakland Park, Florida, 33334

  • GSK Investigational Site

    Orlando, Florida, 32804

  • GSK Investigational Site

    Phoenix, Arizona, 85006

  • GSK Investigational Site

    Sarasota, Florida, 34243

  • GSK Investigational Site

    Somers Point, New Jersey, 08244

  • GSK Investigational Site

    Spokane, Washington, 99204

  • GSK Investigational Site

    Springfield, Massachusetts, 01103

  • GSK Investigational Site

    Springfield, Massachusetts, 01107

  • GSK Investigational Site

    Tampa, Florida, 33614

  • GSK Investigational Site

    Tarzana, California, 91356

  • GSK Investigational Site

    Valhalla, New York, 10595

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20037

  • GSK Investigational Site

    West Hollywood, California, 90069

  • GSK Investigational Site

    West Palm Beach, Florida, 33408

Other trials in United States

Puerto Rico2 sites

  • GSK Investigational Site

    Ponce, 00731

  • GSK Investigational Site

    San Juan, 00909-1711

Other trials in Puerto Rico

About this study

Official title: See Detailed Description.

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.

Read the 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)

Being tested
Half-boosted Fosamprenavir, Full Boosted Fosamprenavir
Keywords
HIV-1 LEXIVA Ritonavir Once-daily
Medical subject headings
HIV Infections, Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Half-boosted FosamprenavirDrug

    Once daily, reduced dose ritonavir-boosted fosamprenavir

  • Full Boosted FosamprenavirDrug

    Also called Fosamprenavir, ritonavir

    Full ritonavir-boosted fosamprenavir

Study groups in NCT00363142
Study groupRoleWhat they receive
FPV/r200Active comparatorFosamprenavir/ritonavir (either 700/100mg BID or 1400/200mg QD)
Receives: Drug: Full Boosted Fosamprenavir
FPV/r100ExperimentalFosamprenavir/ritonavir 1400/100mg QD
Receives: Drug: Half-boosted Fosamprenavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 24

Secondary outcomes (10)

  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

    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.

    Measured: Week 24

  2. 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.

    Measured: Week 24

  3. 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.

    Measured: Baseline and Week 24

  4. 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.

    Measured: Baseline and Week 24

  5. 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.

    Measured: Baseline through Week 24

  6. 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.

    Measured: Baseline through Week 24

  7. 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%.

    Measured: Baseline and Week 24

  8. 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%.

    Measured: Baseline and Week 24

  9. 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.

    Measured: Baseline through Week 24

  10. 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.

    Measured: Weeks 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00363142
Sponsor's protocol ID
LEX106430
Status last verified
Oct 2010
First submitted
11 Aug 2006
Last updated
5 Nov 2010

Publications

  • 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.

    PubMed 21126954

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Half-boosted Fosamprenavir and Full Boosted Fosamprenavir in people with HIV Infection and Infection, Human Immunodeficiency Virus, run by GlaxoSmithKline at 51 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00363142, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2010.

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