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AzTrials

Infection, Human Immunodeficiency VirusPhase 3VIKING-3NCT01328041

A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.

A Phase 3 study testing dolutegravir in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 89 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this trial is to assess the antiviral activity and safety of a dolutegravir (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults with current or historical failure on an integrase inhibitor (INI) containing regimen. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Infection, Human Immunodeficiency Virus
What is being tested?
dolutegravir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
183 participants
Where
89 sitesin 7 countries
Study dates
May 2011to May 2015
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

  • Screening plasma HIV-1 RNA ≥500 copies/mL
  • ART-experienced, INI-experienced, DTG naïve
  • Experienced virological failure on raltegravir (RAL) or elvitegravir (ELV) regimen
  • The subject's HIV-1 shows resistance to RAL or ELV at Screening or at prior time point of virological failure on RAL or ELV
  • Documented resistance to at least one drug from each of three or more of all approved classes of ART
  • Be able to receive at least one fully active drug as part of the OBR from Day 8
  • Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol)
  • Willing and able to understand and provide signed and dated written informed consent prior to Screening.

Who cannot join

  • Women who are pregnant or breast feeding
  • An active AIDS-defining condition at Screening (except cutaneous Kaposi's sarcoma not requiring systemic therapy or CD4+ <200c/mm3)
  • Moderate to severe hepatic impairment as defined by Child-Pugh classification
  • Anticipated need for HCV therapy during the first 24 weeks of the study
  • Recent history of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding
  • Allergy or intolerance to the study drugs or their components or drugs of their class
Show all 15Show fewer
  • Malignancy within the past 6 months
  • Treatment with an HIV-1 therapeutic vaccine within 90 days of Screening
  • Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any immunomodulator within 28 days of Screening
  • Treatment with any agent, other than licensed ART, with documented activity against HIV-1 in vitro within 28 days of first dose of investigational product
  • Treatment with etravirine, efavirenz, or nevirapine within 14 days of Day 1(etravirine may be used if coadministered with lopinivir/ritonavir or darunavir/ritonavir)
  • Treatment with tipranivir/ritonavir, fosamprenavir, or fosamprenavir/ritonavir within 28 days prior to Screening
  • Verified Grade 4 laboratory abnormality at Screening
  • ALT> 5 times the upper limit of normal (ULN) at Screening
  • ALT ≥ 3X ULN and bilirubin > 1.5 X ULN (with 35% direct bilirubin) at Screening

Trial locations and contacts

89 sites in 7 countries.

89 sites in 7 countries

United States42 sites

  • GSK Investigational Site

    Albany, New York, 12209

  • GSK Investigational Site

    Annandale, Virginia, 22003

  • GSK Investigational Site

    Atlanta, Georgia, 30308

  • GSK Investigational Site

    Augusta, Georgia, 30912

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Beverly Hills, California, 90211

  • GSK Investigational Site

    Boston, Massachusetts, 02115

  • GSK Investigational Site

    Buffalo, New York, 14215

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599

  • GSK Investigational Site

    Dallas, Texas, 75204

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33316

  • GSK Investigational Site

    Fountain Valley, California, 92708

  • GSK Investigational Site

    Ft. Pierce, Florida, 34982

  • GSK Investigational Site

    Houston, Texas, 77004

  • GSK Investigational Site

    Houston, Texas, 77098

  • GSK Investigational Site

    Jackson, Mississippi, 39216-4505

  • GSK Investigational Site

    Lafayette, Louisiana, 70506

  • GSK Investigational Site

    Las Vegas, Nevada, 89106

  • GSK Investigational Site

    Los Angeles, California, 90033

  • GSK Investigational Site

    Los Angeles, California, 90069

  • GSK Investigational Site

    Miami Beach, Florida, 33139

  • GSK Investigational Site

    New Haven, Connecticut, 06510

  • GSK Investigational Site

    New York, New York, 10011

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    Newark, New Jersey, 07103

  • GSK Investigational Site

    Norwalk, Connecticut, 06850

  • GSK Investigational Site

    Orlando, Florida, 32804

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

  • GSK Investigational Site

    Portland, Oregon, 97210

  • GSK Investigational Site

    Providence, Rhode Island, 02906

  • GSK Investigational Site

    San Diego, California, 92103-8208

  • GSK Investigational Site

    San Francisco, California, 94109

  • GSK Investigational Site

    Seattle, Washington, 98104

  • GSK Investigational Site

    The Bronx, New York, 10461

  • GSK Investigational Site

    The Bronx, New York, 10467

  • GSK Investigational Site

    Toledo, Ohio, 43614

  • GSK Investigational Site

    Valhalla, New York, 10595

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20007

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20009

Other trials in United States

France15 sites

  • GSK Investigational Site

    Aulnay-sous-Bois, 93602

  • GSK Investigational Site

    Bobigny, 93009

  • GSK Investigational Site

    Bordeaux, 33000

  • GSK Investigational Site

    Garches, 92380

  • GSK Investigational Site

    Gonesse, 95503

  • GSK Investigational Site

    Marseille, 13003

  • GSK Investigational Site

    Marseille, 13009

  • GSK Investigational Site

    Nice, 06202

  • GSK Investigational Site

    Orléans, 45067

  • GSK Investigational Site

    Paris, 75018

  • GSK Investigational Site

    Paris, 75475

  • GSK Investigational Site

    Paris, 75651

  • GSK Investigational Site

    Paris, 75679

  • GSK Investigational Site

    Paris, 75743

  • GSK Investigational Site

    Paris, 75970

Other trials in France

Canada11 sites

  • GSK Investigational Site

    Hamilton, Ontario, L8N 3Z5

  • GSK Investigational Site

    Montreal, Quebec, H2L 4P9

  • GSK Investigational Site

    Montreal, Quebec, H2L 5B1

  • GSK Investigational Site

    Montreal, Quebec, H2W 1T8

  • GSK Investigational Site

    Montreal, Quebec, H2X 2P4

  • GSK Investigational Site

    Montreal, Quebec, H3G 1A4

  • GSK Investigational Site

    Toronto, Ontario, M4N 3M5

  • GSK Investigational Site

    Toronto, Ontario, M4T 3A7

  • GSK Investigational Site

    Toronto, Ontario, M5B 1L6

  • GSK Investigational Site

    Vancouver, British Columbia, V6Z 1Y6

  • GSK Investigational Site

    Vancouver, British Columbia, V6Z 2C7

Other trials in Canada

Spain8 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Alicante, 03010

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Madrid, 28029

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Seville, 41013

Other trials in Spain

Italy6 sites

  • GSK Investigational Site

    Bagno A Ripoli (FI), Tuscany, 50011

  • GSK Investigational Site

    Bergamo, Lombardy, 24127

  • GSK Investigational Site

    Florence, Tuscany, 50134

  • GSK Investigational Site

    Genoa, Liguria, 16138

  • GSK Investigational Site

    Milan, Lombardy, 20127

  • GSK Investigational Site

    Turin, Piedmont, 10149

Other trials in Italy

Portugal5 sites

  • GSK Investigational Site

    Amadora

  • GSK Investigational Site

    Coimbra, 3030

  • GSK Investigational Site

    Lisbon, 1150

  • GSK Investigational Site

    Lisbon, 1349-019

  • GSK Investigational Site

    Lisbon, 1649-035

Other trials in Portugal

Belgium2 sites

  • GSK Investigational Site

    Brussels, 1000

  • GSK Investigational Site

    Liège, 4000

Other trials in Belgium

About this study

Official title: A Phase III Study to Demonstrate the Antiviral Activity and Safety of Dolutegravir in HIV-1 Infected Adult Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.

The purpose of this trial is to assess the antiviral activity and safety of a dolutegravir (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults with current or historical failure on an integrase inhibitor (INI) containing regimen. The study will assess DTG 50mg twice daily administered initially with the current failing ART regimen but then with an optimised background ART regimen (OBR) after Day 7. The first analyses will be conducted after the last subject enrolled has completed 24 weeks. Subjects may remain on study after Week 24.

Read the detailed description

ING112574 is a Phase 3, multicentre, open-label, single arm study to assess the antiviral activity and safety of DTG containing regimen in HIV-1 infected ART-experienced adults with historical or current evidence of resistance to RAL or ELV. Initially, a minimum of 100 subjects will be enrolled to receive DTG 50mg twice daily with the current failing regimen for 7 days but with OBR from Day 8. Subjects must also have documented genotypic and/or phenotypic resistance to at least one compound in two or more of the other approved classes of ART but must also be able to include at least one fully active drug in the OBR to be started Day 8. The first data cut will take place after the (approximate) 100th subject enrolled completes the Week 24 visit. Enrollment will continue until a further 50 to 100 subjects have been recruited. All subjects who successfully complete 24 weeks of treatment will continue to have access to DTG until it is locally available as long as they continue to derive clinical benefit.

ViiV Healthcare is the sponsor of this study.

Being tested
dolutegravir
Keywords
GSK1349572, resistance to raltegravir or elvitegravir, Integrase inhibitor, ART-experienced, dolutegravir
Medical subject headings
Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dolutegravirDrug

    50 mg twice daily

Study groups in NCT01328041
Study groupRoleWhat they receive
dolutegravirExperimentaldolutegravir plus background antiretroviral therapy optimised at Day 8
Receives: Drug: dolutegravir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Baseline in Plasma HIV-1 RNA at Day 8

    Mean change from Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 8 was calculated as the Day 8 value minus the Baseline value. The last observation was carried forward if a participant had missed the Day 8 visit. The Baseline observation was carried forward if a participant had discontinued the treatment before Day 8. Blood samples for assessment of HIV-1 RNA levels were collected at Baseline and Day 8.

    Measured: Baseline and Day 8

  2. Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 24

    The number of participants who had viral load <50 copies/mL at Week 24 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.

    Measured: Week 24

  3. Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48

    The number of participants who had viral load <50 copies/mL at Week 48 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.

    Measured: Week 48

  4. Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)

    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.

    Measured: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

  5. Number of Participants With Adverse Events of the Indicated Severity, Per the Division of Acquired Immune Deficiency Syndrome (DAIDS) Grading Scale

    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. AE/SAE severity was graded according to the DAIDS grading scale. The DAIDS displays events as Grades 1-4 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, potentially life threatening.

    Measured: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

  6. Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade

    The severity of clinical chemistry toxicities was graded according to the DAIDS toxicity scale. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.

    Measured: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

  7. Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade

    The severity of hematology toxicities was graded according to the DAIDS. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.

    Measured: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

Secondary outcomes (12)

  1. Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48

    The number of participants with plasma HIV-1 RNA less than 400 and 50 copies (c)/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40 and 48 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the par. was on treatment within the VOI analysis window

    Measured: Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48

  2. Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion

    The number of participants with plasma HIV-1 RNA less than 400 and 50 copies (c)/mL was assessed at Weeks 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180 using data of observed cases. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

    Measured: From Week 48 every 12 weeks up to study completion.

  3. Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion

    Mean change from Baseline in plasma HIV-1 RNA was assesseed at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, 48 , 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 using data of the observed cases. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

    Measured: Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study completion (Up to Week 180)

  4. Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48

    Absolute values for CD4+ cell counts were assessed at Baseline, Day 8 and Weeks 4, 8, 12, 16, and 24, and absolute values for CD8+ cell counts were assessed at Baseline and Weeks 4, 12, 24, and 48.

    Measured: Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48

  5. Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion

    Median change from Baseline in CD4+ cell counts was assessed at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

    Measured: Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180. v

  6. Ratio of CD4+/CD8+ Cell Count at Baseline and Weeks 4, 12, 24, and 48

    The ratio of CD4+/CD8+ cell count (measured in cells/mm^3) was assessed at Baseline and at Weeks 4, 12, 24, and 48. The ratio was calculated as the CD4+ cell count divided by CD8+ cell count.

    Measured: Baseline; Weeks 4, 12, 24, and 48

  7. Number of Participants With HIV-1 Disease Progression (Acquired Immune Deficiency Syndrome [AIDS] or Death)

    The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).

    Measured: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

  8. Cmax and Ctau of DTG

    The maximum plasma concentration (Cmax) and the concentration at the end of a dosing interval (Ctau) of DTG were assessed by a population pharmacokinetic (PK) modeling approach using pooled DTG PK data from multiple studies. For this study, blood samples for pharmacokinetic assessments were collected pre-dose on Day 8 and at Weeks 4 and 24, at 1-3 hours post-dose on Day 8, and at 1-3 hours or 4-12 hours post-dose at Weeks 4 and 24.

    Measured: Day 8, Week 4, and Week 24

  9. AUC(0-tau) and AUC(0-24) of DTG

    The area under the time concentration curve over the dosing interval (AUC[0-tau]) and from 0 to 24 hours (AUC[0-24]) of DTG was assessed by a population PK modeling approach using pooled DTG PK data from multiple studies. For this study, blood samples for pharmacokinetic assessments were collected pre-dose on Day 8 and at Weeks 4 and 24, at 1-3 hours post-dose on Day 8, and at 1-3 hours or 4-12 hours post-dose at Weeks 4 and 24.

    Measured: Day 8, Week 4, and Week 24

  10. C0 Assessment of DTG

    The plasma DTG concentration immediately prior to dosing at steady state (C0) was assessed at Day 8, Week 4, and Week 24. Blood samples for pharmacokinetic assessments were collected pre-dose and 1-3 hours post-dose on Day 8 and at Week 4 and 4-12 hours post-dose at Week 24. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Parameter Population.

    Measured: Day 8, Week 4, and Week 24

  11. Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance

    An analysis of changes at specific amino acids in the IN coding region associated with resistance to raltegravir, elvitegravir, or DTG was performed at Day 1 and at the time of PDVF. PDVF is a <0.5 log10 copies(c)/mL decrease in plasma HIV-1 RNA at Day 8 unless the absolute value is <400 c/mL. PDVF after Day 8 is defined as virological non-respones (decrease in plasma HIV-1 RNA of <1 log10 c/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA <400 c/mL and confirmed plasma HIV-1 RNA levels >=400 c/mL on or after Week 24) and virological rebound (confirmed rebound in plasma HIV-1 RNA levels to >=400 c/mL after prior confirmed suppression to <400 c/mL and confirmed plasma HIV-1 RNA levels >1 log10 c/mL above the nadir value [nadir: >=400 c/mL]).

    Measured: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

  12. Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance

    The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF is defined as a <0.5 log10 copies/mL decrease in plasma HIV-1 RNA at Day 8 unless the absolute value is <400 copies/mL. PDVF after Day 8 was defined for virological non-response (decrease in plasma HIV-1 RNA of less than 1 log10 copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA <400 copies/mL and confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24) and virological rebound (confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL and confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL).

    Measured: From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionMay 2012
  4. Study completionMay 2015

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01328041
Sponsor's protocol ID
112574
Acronym
VIKING-3
Status last verified
Dec 2015
First submitted
31 Mar 2011
Last updated
7 Jan 2016
Data monitoring committee
Yes

Publications

  • Eron JJ, Clotet B, Durant J, Katlama C, Kumar P, Lazzarin A, Poizot-Martin I, Richmond G, Soriano V, Ait-Khaled M, Fujiwara T, Huang J, Min S, Vavro C, Yeo J; VIKING Study Group. Safety and efficacy of dolutegravir in treatment-experienced subjects with raltegravir-resistant HIV type 1 infection: 24-week results of the VIKING Study. J Infect Dis. 2013 Mar 1;207(5):740-8. doi: 10.1093/infdis/jis750. Epub 2012 Dec 7.

    PubMed 23225901

  • Castagna A, Marcon I, Du F, Li B, Wang M, Clark A, Donovan C, Jones B, Prakash M. Similar Efficacy, Safety, and Immune Improvement Through 96 Weeks in Individuals With Limited HIV-1 Treatment Options Using Twice-Daily Dolutegravir- or Fostemsavir-based Regimens. Open Forum Infect Dis. 2026 Aug 8;13(9):ofag487. doi: 10.1093/ofid/ofag487. eCollection 2026 Sep.

    PubMed 42703616

  • Castagna A, Maggiolo F, Penco G, Wright D, Mills A, Grossberg R, Molina JM, Chas J, Durant J, Moreno S, Doroana M, Ait-Khaled M, Huang J, Min S, Song I, Vavro C, Nichols G, Yeo JM; VIKING-3 Study Group. Dolutegravir in antiretroviral-experienced patients with raltegravir- and/or elvitegravir-resistant HIV-1: 24-week results of the phase III VIKING-3 study. J Infect Dis. 2014 Aug 1;210(3):354-62. doi: 10.1093/infdis/jiu051. Epub 2014 Jan 19.

    PubMed 24446523

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dolutegravir in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 89 sites in 7 countries.

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 8 inclusion and 15 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 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, France, Canada, Spain, Italy and 2 more countries. 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 21 Jul 2014). 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?

Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 (time frame: Baseline and Day 8). The study lists 7 primary outcomes in all. 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 NCT01328041, which also lists 3 linked publications.

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 7 Jan 2016.

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