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Abacavir/Lamivudine Versus Emtricitabine/Tenofovir Both In Combination With Lopinavir/Ritonavir For The Treatment Of HIV

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infection

Intervention: emtricitabine/tenofovir (Drug); abacavir/lamivudine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

This study was designed to test the safety and effectiveness of EPZICOM(abacavir/lamivudine) and TRUVADA (emtricitabine/tenofovir) for the treatment of HIV infection when both are used in combination with KALETRA (lopinavir/ritonavir) over 96 weeks

Clinical Details

Official title: A 96-Week, Phase IV, Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of EPZICOM Versus TRUVADA Administered in Combination With KALETRA in Antiretroviral-Naive HIV-1 Infected Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.

Secondary outcome:

Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48

Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96

Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL

Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL

Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96

Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL

Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL

Median Change From Baseline in HIV-1 RNA at Week 48 and 96

Median Change From Baseline in CD4+ Cells at Weeks 48 and 96

Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96

Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks

Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility

Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria:

- Males as females at least 18 years old. (A female is eligible to enter and

participate in this study if she is of: non child-bearing potential, child bearing potential with a negative pregnancy test and agrees to approved contraception methods, or agreement for complete abstinence.)

- Subject is antiretroviral-naïve (defined as having ≤14 days of prior therapy with any

NRTI and no prior therapy with either a PI or NNRTI).

- Subject has plasma HIV-1 RNA ≥ 1,000 copies/mL at screening.

- Subject is willing and able to understand and provide written informed consent prior

to participation in this study. Exclusion criteria:

- Subject has an active or acute CDC Clinical Category C event (exclusive of cutaneous

Kaposi's sarcoma) at screening. Treatment for the acute event must have been completed at least 30 days prior to screening.

- Subject is enrolled in one or more investigational drug protocols, which may impact

HIV-1 RNA suppression.

- Subject is, in the opinion of the investigator, unable to complete the 96-week dosing

period and protocol evaluations and assessments.

- Subject is either pregnant or breastfeeding.

- Subject has an ongoing clinically relevant pancreatitis or clinically relevant

hepatitis at screening.

- Subject suffers from a serious medical condition, such as cirrhosis, diabetes,

congestive heart failure, cardiomyopathy or other cardiac dysfunction, which in the opinion of the investigator would compromise the safety of the subject.

- Subject has a pre-existing mental, physical, or substance abuse disorder which, in

the opinion of the investigator, may interfere with the subject's ability to comply with the dosing schedule and protocol evaluations and assessments.

- Subject has a history of inflammatory bowel disease or malignancy, intestinal

ischemia, malabsorption, or other gastrointestinal dysfunction which may interfere with drug absorption or render the subject unable to take oral medication.

- Subject has any acute laboratory abnormality at screening, which, in the opinion of

the investigator, precludes the subject's participation in the study of an investigational compound. Any grade 4 laboratory abnormality will exclude a subject from study participation.

- Subject has estimated creatinine clearance <50 mL/min via Cockroft-Gault method.

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 times the upper

limit of normal (ULN).

- Subject has required treatment with radiation therapy or cytotoxic chemotherapeutic

agents within 28 days prior to screening, or has an anticipated need for these agents within the study period.

- Subject requires treatment with immunomodulating agents (such as systemic

corticosteroids, interleukins, vaccines, or interferons) within 28 days prior to Screen, or subject has received an HIV-1 immunotherapeutic vaccine within 90 days prior to Screen. Asthmatic subjects using inhaled corticosteroids are eligible for enrollment.

- Subject requires treatment with foscarnet, hydroxyurea or other agents with

documented activity against HIV-1 in vitro within 28 days of study administration.

- Subjects who require treatment with the prohibited medications within 28 days of

commencement of investigational product, or an anticipated need during the study.

- Subject has a history of allergy to any of the study drugs or any excipients therein

Locations and Contacts

GSK Investigational Site, Ponce 00731, Puerto Rico

GSK Investigational Site, San Juan 00909-1711, Puerto Rico

GSK Investigational Site, Phoenix, Arizona 85006, United States

GSK Investigational Site, Phoenix, Arizona 85012, United States

GSK Investigational Site, Tucson, Arizona 85745, United States

GSK Investigational Site, Beverly Hills, California 90210, United States

GSK Investigational Site, Fountain Valley, California 92708, United States

GSK Investigational Site, Garden Grove, California 92845, United States

GSK Investigational Site, Long Beach, California 90813, United States

GSK Investigational Site, Los Angeles, California 90069, United States

GSK Investigational Site, Newport Beach, California 92663, United States

GSK Investigational Site, Oakland, California 94602, United States

GSK Investigational Site, Oakland, California 94609, United States

GSK Investigational Site, Denver, Colorado 80204, United States

GSK Investigational Site, Denver, Colorado 80220, United States

GSK Investigational Site, Denver, Colorado 80205, United States

GSK Investigational Site, Glastonbury, Connecticut 06033, United States

GSK Investigational Site, Norwalk, Connecticut 06851, United States

GSK Investigational Site, Washington, District of Columbia 20007, United States

GSK Investigational Site, Washington, District of Columbia 20009, United States

GSK Investigational Site, Washington, District of Columbia 20037, United States

GSK Investigational Site, Fort Lauderdale, Florida 33316, United States

GSK Investigational Site, Fort Lauderdale, Florida 33308, United States

GSK Investigational Site, Fort Lauderdale, Florida 33306, United States

GSK Investigational Site, Fort Myers, Florida 33901, United States

GSK Investigational Site, Key West, Florida 33040, United States

GSK Investigational Site, Miami, Florida 33136, United States

GSK Investigational Site, Plantation, Florida 33317, United States

GSK Investigational Site, Port St. Lucie, Florida 34952, United States

GSK Investigational Site, Sarasota, Florida 34243, United States

GSK Investigational Site, Sarasota, Florida 34239, United States

GSK Investigational Site, Tampa, Florida 33602, United States

GSK Investigational Site, Tampa, Florida 33614, United States

GSK Investigational Site, Atlanta, Georgia 30308/30309, United States

GSK Investigational Site, Atlanta, Georgia 30308, United States

GSK Investigational Site, Atlanta, Georgia 30339, United States

GSK Investigational Site, Augusta, Georgia 30912, United States

GSK Investigational Site, Decatur, Georgia 30033, United States

GSK Investigational Site, Chicago, Illinois 60612, United States

GSK Investigational Site, Chicago, Illinois 60637, United States

GSK Investigational Site, Chicago, Illinois 60657, United States

GSK Investigational Site, Maywood, Illinois 60153, United States

GSK Investigational Site, Lexington, Kentucky 40536, United States

GSK Investigational Site, Louisville, Kentucky 40202, United States

GSK Investigational Site, Baltimore, Maryland 21201, United States

GSK Investigational Site, St. Louis, Missouri 63108, United States

GSK Investigational Site, Las Vegas, Nevada 89102, United States

GSK Investigational Site, Hillsborough, New Jersey 08844, United States

GSK Investigational Site, Newark, New Jersey 07102, United States

GSK Investigational Site, Somers Point, New Jersey 08244, United States

GSK Investigational Site, New York, New York 10011, United States

GSK Investigational Site, New York, New York 10065, United States

GSK Investigational Site, Rochester, New York 14604, United States

GSK Investigational Site, Charlotte, North Carolina 28209, United States

GSK Investigational Site, Greenville, North Carolina 27834, United States

GSK Investigational Site, Toledo, Ohio 43614, United States

GSK Investigational Site, Portland, Oregon 97219, United States

GSK Investigational Site, Philadelphia, Pennsylvania 19140, United States

GSK Investigational Site, West Reading, Pennsylvania 19611, United States

GSK Investigational Site, Columbia, South Carolina 29206, United States

GSK Investigational Site, Austin, Texas 78751, United States

GSK Investigational Site, Dallas, Texas 75208, United States

GSK Investigational Site, Dallas, Texas 75246, United States

GSK Investigational Site, Fort Worth, Texas 76104, United States

GSK Investigational Site, Harlingen, Texas 78550, United States

GSK Investigational Site, Houston, Texas 77027, United States

GSK Investigational Site, Houston, Texas 77030, United States

GSK Investigational Site, Longview, Texas 75604, United States

GSK Investigational Site, Tyler, Texas 75708, United States

GSK Investigational Site, Annandale, Virginia 22003, United States

GSK Investigational Site, Charlottesville, Virginia 22908, United States

GSK Investigational Site, Hampton, Virginia 23666, United States

GSK Investigational Site, Lynchburg, Virginia 24501, United States

GSK Investigational Site, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: July 2005
Last updated: June 3, 2010

Page last updated: August 23, 2015

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