Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure



Status:Completed
Conditions:HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:December 2014
End Date:September 2017

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Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure (ASPIRE) Study

HIV-1 infected subjects with CD4 nadir > 200 cells/mm3, no history of virologic failure and
plasma HIV RNA <50 copies/mL for at least 48 weeks while on any United States Department of
Health and Human Services (DHHS) recommended or alternative three-drug antiretroviral regimen
will be randomized to dolutegravir (DTG) plus lamivudine (Arm 1) or continuation of their
current regimen (Arm 2) for 48 weeks. The primary endpoint is virologic failure defined as
confirmed plasma HIV-1 RNA > 50 copies/mL before or at Week 24

DESIGN HIV-1 infected subjects with CD4 nadir > 200 cells/mm3, no history of virologic
failure and plasma HIV RNA <50 copies/mL for at least 48 weeks while on any United States
Department of Health and Human Services (DHHS) recommended or alternative three-drug
antiretroviral regimen will be randomized to dolutegravir (DTG) plus lamivudine (Arm 1) or
continuation of their current regimen (Arm 2) for 48 weeks. The primary endpoint is virologic
failure defined as confirmed plasma HIV-1 RNA > 50 copies/mL before or at Week 24

All subjects will undergo routine monitoring including plasma HIV-1 RNA, CD4/CD8 count,
hematology, chemistry and fasting lipids. Resistance testing will be done in all patients who
experience virologic failure. Single-copy HIV-1 assay will be done to quantify residual
viremia.

DURATION 48 weeks

SAMPLE SIZE 90 subjects

POPULATION HIV-1-infected men and women, 18 years and older, with CD4 nadir > 200 cells/mm3,
no baseline resistance, no history of virologic failure, and HIV RNA <50 copies/mL for at
least 48 weeks prior to study entry while on any DHHS recommended or alternative three-drug
regimen

REGIMEN Subjects will be randomized (1:1) to:

Arm 1: dolutegravir 50 mg plus lamivudine 300 mg once daily OR Arm 2: Continue current DHHS
recommended or alternative three-drug antiretroviral regimen

Inclusion Criteria:

- HIV-1 Infection

- HIV-1 RNA <50 copies/mL on all measurements within 48 weeks prior to study entry while
on any DHHS recommended or alternative three-drug antiretroviral regimen. (A history
of switching for simplification and/or tolerability is allowed. At least two
measurements within the previous 48 weeks are required prior to study screening.)

- No history of virologic failure, defined as consecutive HIV RNA > 50 copies/mL after
12 months of initiating ART. An isolated (non-consecutive) HIV RNA > 50 copies/mL (but
less than 400 copies/mL) is permitted after 12 months of initiating ART but not in the
48-week window prior to study entry.

- Screening plasma HIV RNA < 20 copies/mL using the COBAS AmpliPrep/COBAS TaqMan HIV-1
Test V2.0, obtained within 45 days prior to study entry

- Nadir CD4 count >200 cells/mm

- Pretreatment genotype documenting no mutations in the protease or reverse
transcriptase genes

- No known resistance to integrase inhibitors

- Laboratory values obtained within 45 days prior to study entry:

ANC >750 Hemoglobin >10 g/dL Platelets >50,000 Calculated creatinine clearance (CrCl) >50
mL/min

- Negative serum or urine pregnancy test

- Men and women age greater or equal to 18 years.

- Ability to continue current regimen (i.e, have uninterrupted access)

- No evidence of chronic hepatitis B

Exclusion Criteria:

- Serious illness or AIDS-related complication within 21 days of screening requiring
systemic treatment and/or hospitalization

- Treatment within 30 days prior to study entry with immune modulators

- Vaccination within 7 days

- Active HCV treatment or anticipated need for treatment within study period. (HCV
infection alone is not exclusionary)

- Unstable liver disease or severe hepatic impairment

- Known allergy or hypersensitivity to DTG or lamivudine.

- Active drug or alcohol use or dependence that could interfere with adherence to study
requirements

- ALT (alanine aminotransferase) >5 x ULN (upper limit of normal) OR ALT >3 x ULN and
total bilirubin >1.5 x ULN (with 35% direct bilirubin)
We found this trial at
7
sites
New York, New York 10021
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Vincent Marconi, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Paul Sax, MD
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Babafemi Taiwo, MBBS
Phone: 312-695-5012
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Carl Fichtenbaum, MD
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Susan Koletar, MD
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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San Diego, California 92093
Principal Investigator: Constance Benson, MD
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San Diego, CA
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