DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE)

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

Condition(s) targeted: Infection, Human Immunodeficiency Virus

Intervention: Reyataz + Norvir + Truvada (Drug); Reyataz + Epzicom (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: ViiV Healthcare

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

Summary

This study is designed to compare the efficacy and safety of simplifying therapy from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to a regimen of ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV in virologically suppressed, HIV-1 infected, HLA-B*5701 negative subjects for 48 weeks.

Clinical Details

Official title: A Prospective, Randomized, Multicenter, Open-Label Study to Compare the Efficacy and Safety of Simplifying From a Regimen of Atazanavir (ATV) + Ritonavir (RTV) + Tenofovir/Emtricitabine to ATV + Abacavir/Lamivudine Without RTV in Virologically Suppressed, HIV-1 Infected, HLA-B*5701 Negative Subjects

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

Primary outcome: Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c)/Milliliter (mL) at the Week 24 Visit: TLOVR Analysis

Secondary outcome:

Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses

Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses

Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis

Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: TLOVR Analysis

Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses

Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses

Change From Baseline in HIV-1 RNA at Week 24

Change From Baseline in HIV-1 RNA at Week 48

Change From Baseline in CD4+ Cell Count at Week 24

Change From Baseline in CD4+ Cell Count at Week 48

Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24

Change From Baseline in Cholesterol/HDL Ratio at Week 24

Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48

Change From Baseline in Cholesterol/HDL Ratio at Week 48

Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24

Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 48

Number of Participants Who Experienced Death and/or Disease Progression

Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24

Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48

Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir

Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir

Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group

Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group

Detailed description: A prospective, randomized, multicenter, open-label study to compare the efficacy and safety of simplifying from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV for 48 weeks in virologically suppressed, HIV-1 infected, HLA-B*5701 negative subjects. ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Eligibility

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

Criteria:

Inclusion Criteria:

- Subject is an adult (greater than or equal to 18 years) with documented HIV-1

infection

- Subject is a male or female of non-childbearing potential (physiologically incapable

of becoming pregnant, is pre-menarchal or post-menopausal) or child-bearing potential with a negative pregnancy test who agrees to avoid pregnancy by sexual abstinence or utilization of a highly effective method of birth control throughout the study period

- Subject is receiving a once-daily regimen of ATV (300mg) + RTV (100mg) + TDF/FTC

(300mg/200mg) for at least 6 months prior to or by the first day of screening. ATV + RTV + TDF/FTC must be the subejct's INITIAL regimen or FIRST or SECOND SWITCH regimen. If ATV + RTV + TDF/FTC is subject's first or second switch regimen, then subject may ONLY have received the following prior regimens: a) any currently licensed non-nucleoside reverse transcriptase inhibitor (NNRTI) + TDF/FTC or ZDV/3TC; b) RTV-boosted PI with TDF/FTC or ZDV/3TC; or c) an alternative regimen not listed above after approval by Sponsor.

- Subject is virologically suppressed on ATV + RTV + TDF/FTC defined as HIV-1 RNA copies/mL at 2 consecutive timepoints, one of which is at Screening and the other at least 28 days prior to Screening Exclusion Criteria:

- Subject has evidence of virologic failure

- Subject has any known HIV genotyping results indicating HIV virus contains any of the

following resistance mutations in reverse transcriptase including K65R, K70E, L74V, M184I/V or Y115F, a combination of two or more thymidine analog mutations including M41L, D67N, K70R, K219Q or E that include changes at either L210 or T215), or 3 or more of the following HIV-1 protease mutations associated with atazanavir resistance: D30, V32, M36, M46, I47, G48, I50, I54, A71, G73, V77, V82, I84, N88, and L90

- Subject is HLA-B*5701 positive

- Subject has hypersensitivity to any component of the study drugs

- SUbject is pregnant or breastfeeding

- Subject is enrolled in one or more investigational drug protocols within 30 days of

screening

- Subject has an active Center for Disease Control and Prevention (CDC) Category C

disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial

- Subject has ongoing clinically relevant hepatitis at screening and/or positive for

Hepatitis B (+ HbsAg)

- Subject has a creatinine clearance <50 mL/min via the Cockcroft-Gault method

- Subject has a verified Grade 4 laboratory abnormality at screening unless the

Investigator can provide a compelling explanation (e. g. elevated CPK due to exercise) for the laboratory result(s) and has the assent of the Sponsor

- Subject has any other laboratory abnormality or medical condition at screening,

which, in the opinion of the investigator, would preclude the subject's participation in the study

- Subject has had an immunization within 30 days prior to first dose of investigational

product

- Subject has had any exposure to treatment with immunomodulating agents (such as

systemic corticosteroids, interleukins, or interferons) or receipt of an HIV-1 immunotherapeutic vaccine within 90 days prior to screening. Subjects using inhaled corticosteroids or short-course systemic corticosteroids (less than or equal to 14 days) are eligible for enrollment.

- Subject has had treatment with radiation therapy or cytotoxic chemotherapeutic agents

within 90 days prior to screening, or has an anticipated need for these agents within the study period

- Subject has had treatment within 30 days prior to first dose of investigational

product for or an anticipated need during the study of any medications which can have interactions with the study medications, TDF, FTC, ABC, 3TC, ATV and/or RTV, as described in current product labelling

- Subject has had treatment with any previous abacavir-containing regimen

Locations and Contacts

GSK Investigational Site, Ponce 00717, Puerto Rico

GSK Investigational Site, San Juan 00909, Puerto Rico

GSK Investigational Site, Hobson City, Alabama 36201, United States

GSK Investigational Site, Phoenix, Arizona 85012, United States

GSK Investigational Site, Phoenix, Arizona 85015, United States

GSK Investigational Site, Bakersfield, California 93301, United States

GSK Investigational Site, Beverly Hills, California 90211, United States

GSK Investigational Site, Fountain Valley, California 92708, 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, San Diego, California 92103, United States

GSK Investigational Site, San Francisco, California 94109, United States

GSK Investigational Site, Denver, Colorado 80220, 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, Daytona Beach, Florida 32117, United States

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

GSK Investigational Site, Fort Pierce, Florida 34982, United States

GSK Investigational Site, Miami Beach, Florida 33139, United States

GSK Investigational Site, Miami, Florida 33133, United States

GSK Investigational Site, Miami, Florida 33137, United States

GSK Investigational Site, Orlando, Florida 32803, United States

GSK Investigational Site, West Palm Beach, Florida 33401, United States

GSK Investigational Site, Wilton Manor, Florida 33305, United States

GSK Investigational Site, Atlanta, Georgia 30339, United States

GSK Investigational Site, Atlanta, Georgia 30309, United States

GSK Investigational Site, Savannah, Georgia 31401, United States

GSK Investigational Site, Boise, Idaho 83704, United States

GSK Investigational Site, Chicago, Illinois 60613, United States

GSK Investigational Site, Berkeley, Michigan 48072, United States

GSK Investigational Site, East Lansing, Michigan 48824, United States

GSK Investigational Site, Minneapolis, Minnesota 55415, United States

GSK Investigational Site, Kansas City, Missouri 64106, United States

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

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

GSK Investigational Site, Valhalla, New York 10595, United States

GSK Investigational Site, Chapel Hill, North Carolina 27599, United States

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

GSK Investigational Site, Memphis, Tennessee 38103, United States

GSK Investigational Site, Dallas, Texas 75246, United States

GSK Investigational Site, Houston, Texas 77098, United States

GSK Investigational Site, Lynchburg, Virginia 24501, United States

GSK Investigational Site, Spokane, Washington 99204, United States

Additional Information

ViiV Healthcare Website

Click here for more information about Epzicom

Related publications:

Robertson K, Maruff P, Wohl D, et al. Similar cognition outcomes after 24 weeks for tenofovir/FTC + atazanavir/r (ATV/r)-experienced HIV+ subjects or subjects simplifying to abacavir/3TC+ATV. Published at: Conference on Retroviruses and Opportunistic Infections - 20th Annual; March 3-6, 2013; Atlanta, GA.

Starting date: April 2010
Last updated: October 24, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017