HIV InfectionPhase 3ASPIRENCT02263326
Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure
A Phase 3 study testing dolutegravir, lamivudine and Continue current antiretroviral regimen in people with HIV Infection, run by Babafemi Taiwo at 7 sites in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- dolutegravir, lamivudine and Continue current antiretroviral regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2014to Sep 2017
- 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
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Emory University
Atlanta, Georgia
Brigham and Women's Hospital
Boston, Massachusetts
Northwestern University
Chicago, Illinois, 60611
University of Cincinnati
Cincinnati, Ohio
The Ohio State University
Columbus, Ohio
Cornell University
New York, New York
University of California San Diego
San Diego, California
About this study
Official title: 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
Read the detailed description
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
- Conditions
- HIV Infection
- Being tested
- dolutegravir, lamivudine, Continue current antiretroviral regimen
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dolutegravirDrug
Also called TIVICAY, DTG
50 mg tablet by mouth once daily for 48 weeks
lamivudineDrug
Also called EPIVIR, 3TC
300 mg tablet by mouth once daily for 48 weeks
Continue current antiretroviral regimenDrug
Continue current DHHS recommended or alternative three-drug antiretroviral regimen
| Study group | Role | What they receive |
|---|---|---|
| dolutegravir plus lamivudine | Experimental | dolutegravir 50 mg plus lamivudine 300 mg once daily Receives: Drug: dolutegravir; Drug: lamivudine |
| Continue current ART regimen | Active comparator | Continue current DHHS recommended or alternative three-drug antiretroviral regimen Receives: Drug: Continue current antiretroviral regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Treatment Failure
Proportion of participants with treatment failure (defined as virologic failure (HIV RNA >50 copies/mL), loss to follow-up, or treatment discontinuation) between those who switch to DTG + lamivudine and those who continue their current ART regimen
Measured: 24 weeks
Secondary outcomes (6)
Proportion of Participants With Virologic Success
Proportion of participants with virologic success (<50 copies/mL) based on FDA snapshot definition
Measured: 48 weeks
Change in CD4 Count From Baseline to Week 48
Change in CD4 count between arms will be presented in the attached statistical analysis table
Measured: Baseline and 48 weeks
Change in Total Cholesterol From Baseline to Week 48
Change in Total Cholesterol between arms will be presented in the attached statistical analysis table
Measured: Baseline and 48 weeks
Change in LDL Cholesterol From Baseline to Week 48
Change in Low-density lipoprotein (LDL) cholesterol between arms will be presented in the attached statistical analysis table
Measured: Baseline and Week 48
Change in Creatinine Clearance From Baseline to Week 48
Change in Creatinine Clearance between arms will be presented in the attached statistical analysis table
Measured: Baseline and Week 48
Drug Resistance Associated Mutations
Drug resistance mutations measured by HIV genotyping in patients with confirmed virologic failure
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babafemi Taiwo
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor-investigator, Babafemi Taiwo, Northwestern University
- Investigators
- Babafemi Taiwo, MBBS, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263326
- Sponsor's protocol ID
- ASPIRE
- Acronym
- ASPIRE
- Status last verified
- Oct 2019
- First submitted
- 6 Oct 2014
- Last updated
- 14 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Taiwo BO, Marconi VC, Berzins B, Moser CB, Nyaku AN, Fichtenbaum CJ, Benson CA, Wilkin T, Koletar SL, Colasanti J, Acosta EP, Li JZ, Sax PE. Dolutegravir Plus Lamivudine Maintains Human Immunodeficiency Virus-1 Suppression Through Week 48 in a Pilot Randomized Trial. Clin Infect Dis. 2018 May 17;66(11):1794-1797. doi: 10.1093/cid/cix1131.
PubMed 29293895
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure (ASPIRE) Study
- ClinicalTrials.gov ID
- NCT02263326
- Acronym / sponsor ID
- ASPIRE / ASPIRE
- Conditions
- HIV Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Babafemi TaiwoUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- Dec 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Posted 13 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dolutegravir plus lamivudine | Experimental | Drug: dolutegravir, Drug: lamivudinedolutegravir 50 mg plus lamivudine 300 mg once daily |
| Continue current ART regimen | Active comparator | Drug: Continue current antiretroviral regimenContinue current DHHS recommended or alternative three-drug antiretroviral regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dolutegravirAlso: TIVICAY, DTG50 mg tablet by mouth once daily for 48 weeks | Drug | dolutegravir plus lamivudine |
| lamivudineAlso: EPIVIR, 3TC300 mg tablet by mouth once daily for 48 weeks | Drug | dolutegravir plus lamivudine |
| Continue current antiretroviral regimenContinue current DHHS recommended or alternative three-drug antiretroviral regimen | Drug | Continue current ART regimen |
Primary outcome
Proportion of Participants With Treatment Failure
Time frame: 24 weeks
Proportion of participants with treatment failure (defined as virologic failure (HIV RNA >50 copies/mL), loss to follow-up, or treatment discontinuation) between those who switch to DTG + lamivudine and those who continue their current ART regimen
6 secondary outcomes
Proportion of Participants With Virologic Success
Time frame: 48 weeks
Change in CD4 Count From Baseline to Week 48
Time frame: Baseline and 48 weeks
Change in Total Cholesterol From Baseline to Week 48
Time frame: Baseline and 48 weeks
Change in LDL Cholesterol From Baseline to Week 48
Time frame: Baseline and Week 48
Change in Creatinine Clearance From Baseline to Week 48
Time frame: Baseline and Week 48
Drug Resistance Associated Mutations
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29293895Taiwo BO, Marconi VC, Berzins B, Moser CB, Nyaku AN, Fichtenbaum CJ, Benson CA, Wilkin T, Koletar SL, Colasanti J, Acosta EP, Li JZ, Sax PE. Dolutegravir Plus Lamivudine Maintains Human Immunodeficiency Virus-1 Suppression Through Week 48 in a Pilot Randomized Trial. Clin Infect Dis. 2018 May 17;66(11):1794-1797. doi: 10.1093/cid/cix1131.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Babafemi Taiwo, MBBS principal investigator
Northwestern University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dolutegravir, lamivudine and Continue current antiretroviral regimen in people with HIV Infection, run by Babafemi Taiwo at 7 sites in United States.
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 13 inclusion and 8 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 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 13 Nov 2018). 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?
Proportion of Participants With Treatment Failure (time frame: 24 weeks). 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 NCT02263326, 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 14 Oct 2019.