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A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9350-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

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

Condition(s) targeted: HIV-1 Infection

Intervention: Cobicistat (Drug); Ritonavir (Drug); Atazanavir (Drug); FTC/TDF (Drug); Placebo to match COBI (Drug); Placebo to match RTV (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Marshall Fordyce, MD, Study Chair, Affiliation: Gilead Sciences

Summary

The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV/co) plus emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus FTC/TDF in HIV-1 infected, antiretroviral treatment-naive adult subjects. Subjects will be randomized in a 2: 1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. After Week 48, subjects will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded, at which point all subjects will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive ATV/co+FTC/TDF until COBI tablets become commercially available, or until Gilead Sciences elects to terminate the study.

Clinical Details

Official title: A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9350-boosted Atazanavir (ATV/GS-9350) Compared to Ritonavir-boosted Atazanavir (ATV/r) in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

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

Primary outcome: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24

Secondary outcome:

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

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

Eligibility

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

Criteria:

Inclusion Criteria:

- Ability to understand and sign a written informed consent form

- Plasma HIV-1 RNA levels ≥ 5,000 copies/mL

- No prior use of any approved or experimental anti-HIV drug

- Normal ECG (or if abnormal, determined by the investigator to be not clinically

significant)

- Adequate renal function (estimated glomerular filtration rate ≥ 80 mL/min according

to the Cockcroft-Gault formula)

- Hepatic transaminases ≤ 2. 5 × upper limit of normal

- Total bilirubin ≤ 1. 5 mg/dL, or normal direct bilirubin

- Adequate hematologic function (absolute neutrophil count ≥ 1000/mm^3; platelets ≥

50,000/mm^3; hemoglobin ≥ 8. 5 g/dL)

- Cluster of differentiation 4 (CD4) cell count > 50 cells/µL

- Serum amylase ≤ 1. 5 × ULN (subjects with serum amylase >1. 5 × ULN remained eligible

if serum lipase is ≤ 1. 5 × ULN)

- Normal thyroid-stimulating hormone

- Negative serum pregnancy test (females of childbearing potential only)

- Males and females of childbearing potential must agree to utilize highly effective

contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drugs

- Age ≥ 18 years

- Life expectancy ≥ 1 year

Exclusion Criteria:

- New AIDS-defining condition diagnosed within the 30 days prior to screening

- Documented drug resistance to nucleoside or nucleotide reverse transcriptase

inhibitors (NRTIs), nonnucleoside reverse transcriptase inhibitors (NNRTIs), or primary PI resistance mutation(s)

- Hepatitis B surface antigen positive

- Hepatitis C antibody positive

- Participants experiencing cirrhosis

- Participants experiencing ascites

- Participants experiencing encephalopathy

- Females who are breastfeeding

- Positive serum pregnancy test (female of childbearing potential)

- Vaccinated within 90 days of study dosing

- History or family history of Long QT Syndrome or have a family history of sudden

cardiac death or unexplained death in an otherwise healthy individual under the age of 30 years

- Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac

conduction abnormalities

- Prolonged QTcF (QT interval corrected for heart rate using Fridericia's formula)

interval at screening (eg, a prolongation of the QTcF interval of greater than 450 msec for males and greater than 470 msec for females)

- PR interval greater than or equal to 200 msec or less than or equal to 120 msec on

ECG at screening

- QRS greater than or equal to 120 msec on ECG at screening

- Implanted defibrillator or pacemaker

- Subjects receiving ongoing therapy with any disallowed medications

- Current alcohol or substance use judged to potentially interfere with subject study

compliance

- History of or ongoing malignancy (including untreated carcinoma in-situ) other than

cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma

- Active, serious infections (other than HIV-1 infection) requiring parenteral

antibiotic or antifungal therapy within 30 days prior to baseline

- Participation in any other clinical trial without prior approval

- Medications contraindicated for use with ATV, RTV, FTC, or TDF

- Any known allergies to the excipients of ATV capsules, RTV capsules, COBI tablets or

FTC/TDF tablets

- Any other clinical condition or prior therapy that would make the subject unsuitable

for the study or unable to comply with the dosing requirements

Locations and Contacts

Southwest Center for HIV/AIDS, Phoenix, Arizona 85006, United States

Health for Life Clinic, PLLC, Little Rock, Arkansas 72207, United States

AIDS Healthcare Foundation-Research Center, Beverly Hills, California 90804, United States

The Living Hope Foundation, Long Beach, California 90813, United States

Peter J. Ruane, MD, Inc., Los Angeles, California 90036, United States

Orange Coast Medical Group, Newport Beach, California 92663, United States

David J. Shamblaw, MD Inc., San Diego, California 92103, United States

Metropolis Medical, San Francisco, California 94115, United States

Denver Infectious Disease Consultants, PLLC, Denver, Colorado 80220, United States

Capital Medical Associates PC, Washington, District of Columbia 20036, United States

Dupont Circle Physicians Group, Washington, District of Columbia 20009, United States

Whitman Walker Clinic, Washington, District of Columbia 20009, United States

Gary Richmond, MD, PA, Inc., Fort Lauderdale, Florida 33316, United States

Wohlfeiler, Piperato and Associates, LLC, Miami Beach, Florida 33139, United States

ValuehealthMD, LLC, Orlando, Florida 32806, United States

St. Joseph's Comprehensive Research Institute, Tampa, Florida 33614, United States

AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States

Infectious Disease Specialists of Atlanta (IDSA), Decatur, Georgia 30033, United States

Northstar Medical Center, Chicago, Illinois 60657, United States

Chase Brexton Health Services, Inc., Baltimore, Maryland 21201, United States

Be Well Medical Center, Berkley, Michigan 48072, United States

Central West Healthcare, St. Louis, Missouri 63108, United States

Southampton Healthcare, Inc., St. Louis, Missouri 63139, United States

Saint Michael's Medical Center, Newark, New Jersey 07102, United States

Southwest C.A.R.E. Center, Santa Fe, New Mexico 87505, United States

Rosedale Infectious Diseases, Huntersville, North Carolina 28078, United States

AIDS Arms/ Peabody Health Center, Dallas, Texas 75215, United States

Nicholaos Bellos, MD, PA, Dallas, Texas 75204, United States

Gordon E. Crofoot, MD, PA, Houston, Texas 77098, United States

Therapeutic Concepts, P.A., Houston, Texas 77478, United States

TribalMed, Seattle, Washington 98103, United States

Additional Information

Starting date: May 2009
Last updated: February 5, 2015

Page last updated: August 23, 2015

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