HIV-1 InfectionPhase 2DolatavNCT02542852

A Study of a Nucleoside Sparing Regimen in HIV-1 Infected Patients With Detectable Viremia

A Phase 2 study testing atazanavir 300 mg + ritonavir 100 mg + dolutegravir 50 mg in people with HIV-1 Infection, run by Castagna Antonella at 1 site in Italy.

Completed

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

Official record

Search all trials

Trial summary

Research ipotesis is to assess the efficacy and safety of a nucleos(t)ide sparing regimen of atazanavir/ritonavir 300 mg /100 mg QD + Dolutegravir 50 mg QD for the management of virological failure in HIV-1 infected patients. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: HIV-1 Infection
What is being tested?: atazanavir 300 mg + ritonavir 100 mg + dolutegravir 50 mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteItaly
Study dates: Sep 2015to Dec 2017
Phase: Phase 2
Are there results?: None posted in the registry

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects with age more than 18 years
Willing and able to provide informed consent
Failing a stable (at least 3 months) antiretroviral therapy (HIV-RNA more than 200 copies/ml)
Any CD4 cell count
Virus susceptible to atazanavir, defined as a genotypic mutation score inferior to 15 according to the HIV drug resistance database (Stanford University)
No previous documented virologic failure during an atazanavir-containing regimen

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No previous exposure to integrase inhibitors
Absolute neutrophil count (ANC) more than 500/mm3
Haemoglobin more than 8.0 g/dL
Platelet count more than 60,000/mm3
e-GFR> 60 ml/min using CKD-EPI equation

Who cannot join

Active AIDS-defining condition at Screening
Serious illness requiring systemic treatment and/or hospitalization
Current use of immunomodulant or immunosuppressive drugs
Requirement for any concomitant medications that are prohibited with any study drugs (protocol section 3.6)
History or presence of hypersensitivity to any of the active substances or to the excipients
Alanine aminotransferase (ALT) more than 5 times the upper limit of normal (ULN), OR ALT more than 3xULN and bilirubin more than 1.5xULN (with more than 35 percent direct bilirubin)

Show all 11Show fewer

Subjects positive for Hepatitis B at screening (HBsAg positive)
Subjects with anticipated need for Hepatitis C virus (HCV) therapy during the study
Presence of moderate or severe hepatic impairment (defined as a Class B or C at Child Pugh Classification) or presence of unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice) or known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Pregnancy or pregnancy wish; breastfeeding
Moreover, all clinical conditions reported as an absolute contraindication in the summary of product characteristics of the study drugs, will be considered as exclusion criteria.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Ospedale San Raffaele Scientific Institute
Milan, 20127

Other trials in Italy

About this study

Official title: A Pilot Phase II Study of a Nucleoside Sparing Regimen of Dolutegravir + Atazanavir/r in HIV-1 Infected Patients With Detectable Viremia (DOLATAV Study)

The Primary Objective is to explore the 24-week efficacy of a nucleos(t)ide sparing regimen of atazanavir 300 mg QD/ ritonavir 100 mg QD + Dolutegravir 50 mg QD for the management of virologic failure in HIV-1 infected, integrase inhibitor-naïve subjects.

Read the detailed description

Study design;

24-week prospective, single-arm, monocentric, open label, pilot study Participants will be seen at screening, baseline, day 8 and at week 4, 8, 12, 16, 24.

At each visit the following evaluations will be performed:

clinical assessment.
routine laboratory tests (hematological tests and clinical chemistry) including hemochromocytometric examination with leukocytic formula, creatinine, creatine kinase, transaminases, phosphorus, calcium, alkaline phosphatase, total and direct bilirubin, gammaGT, uric acid, lactate dehydrogenase, urine analysis, glucose, lipid profile, HIV-RNA and CD4 cell counts.

Additional blood samples will be collected at each visit for storage and further determinations.

During follow-up, at different timepoints, patients will additionally undergo:

HbA1c and fasting insulin levels and HOMA-IR determination (baseline, week 12, week 24)
Adherence assessment (questionnaire and/or pills counts) at week 4, 12 and 24.
ECG (baseline and week 24)

Protocol virologic failure is defined as

< 1 log10 decrease in plasma HIV-1 RNA by week 12, with subsequent confirmation, unless plasma HIV-RNA < 200 copies/ml OR
a confirmed rebound in plasma HIV-RNA levels ≥ 50 copies/ml after prior confirmed suppression to < 50 copies/ml OR a confirmed plasma increase in HIV-1 RNA levels > 1log10 copies/ml above the nadir value where nadir is ≥ 50 copies/ml OR
a plasma HIV-1 RNA level ≥ 50 copies/ml at week 24

Subjects who meet a protocol-defined virologic failure during follow-up will be discontinued from the study.

Patients who suppress HIV-1 RNA < 50 cp/ml before week 24 and have a viral blip ≥ 50 copies/ml at week 24 will undergo a plasma HIV-1 RNA re-test to confirm the virologic failure. At virologic failure subjects will perform genotypic and phenotypic tests and a plasma determination of ATV and DTG Cthrough.

No changes in study treatment are allowed with the exception of ritonavir (RTV) discontinuation in patients with hyperbilirubinemia and/or gastrointestinal adverse events judged as RTV-related by the Investigator. In this case, subjects will remain on study using the regimen ATV 400mg QD + DTG 50mg QD. The discontinuation of RTV will not be considered as treatment failure.

In subjects with plasma HIV-RNA < 50 copies/ml at week 24, the study treatment will be successively provided by Italian National Health system.

Conditions: HIV-1 Infection
Being tested: atazanavir 300 mg + ritonavir 100 mg + dolutegravir 50 mg
Keywords: HIV-1

What participants receive

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

atazanavir 300 mg + ritonavir 100 mg + dolutegravir 50 mgDrug
Also called Reyataz 300 mg + norvir 100 mg + tivicay 50 mg
Switch to single arm treatment atazanavir-ritonavir 300-100 mg + dolutegravir 50 mg therapy for 24 weeks

Study groups in NCT02542852
Study group	Role	What they receive
Open label single arm	Experimental	Introduction of treatment regimen with atazanavir 300mg qd + ritonavir 100mg qd + dolutegravir 50mg qd Receives: Drug: atazanavir 300 mg + ritonavir 100 mg + dolutegravir 50 mg

What is being measured

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

Primary endpoint - The proportion of patients with undetectable HIV RNA viral load ( < 50 copies/ml) at week 24
The proportion of patients with undetectable HIV RNA viral load ( < 50 copies/ml) at week 24.
Measured: 24 weeks

Secondary outcomes (9)

proportion of patient with undetactable HIV RNA at week 4 (Virologic efficacy)
proportion of patient with undetactable HIV RNA at week 4
Measured: 4 week
Change from baseline CD4 cell counts (Immunological efficacy)
Change from baseline CD4 cell counts
Measured: 4,8,12,16,24 weeks
Time to achieve undetectability (Virologic efficacy)
Time to achieve undetectability
Measured: Day 8, weeks 4,8,12,16,24
Occurrence of genotyping resistance mutations for PI and INSTI in isolates from patients with virological failure.
Occurrence of genotyping resistance mutations for PI and INSTI in isolates from patients with virological failure.
Measured: 24 week
Atazanavir and Dolutegravir Ctrough (PK evaluation)
Atazanavir and Dolutegravir Ctrough
Measured: Day 8, weeks 4,8,12,16,24
Proportion of patients with adverse events (safety and tolerability).
Proportion of patients with adverse events (any grade, proportion of patients with more than or equal than grade 2 AE, proportion of patients with side effects leading to discontinuation, reason for treatment discontinuation.
Measured: Day 8, weeks 4,8,12,16,24
Changes in lipid, clearance creatinine and glycemic profile from baseline (safety and tolerability)
Changes in lipid, clearance creatinine and glycemic profile from baseline
Measured: weeks 4,8,12,16,24
Change in ECG parameters (safety and tolerability)
Change in ECG parameters
Measured: 24 week
Adherence evaluation
Adherence changes since first evaluation using questionnaire
Measured: 8,12,16,24 weeks

Timeline

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

Sep 2015Dec 2017

First posted7 Sep 2015 (estimated)
Study startSep 2015
Primary completionJun 2016
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for HIV-1 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02542852
Sponsor's protocol ID: Dolatav Study
Acronym: Dolatav
Status last verified: Feb 2024
First submitted: 3 Aug 2015
Last updated: 13 Feb 2024
Results posted: No
Data monitoring committee: No

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
Rathbun RC, Lockhart SM, Miller MM, Liedtke MD. Dolutegravir, a second-generation integrase inhibitor for the treatment of HIV-1 infection. Ann Pharmacother. 2014 Mar;48(3):395-403. doi: 10.1177/1060028013513558. Epub 2013 Nov 19.
PubMed 24259658
Kozal MJ, Lupo S, DeJesus E, Molina JM, McDonald C, Raffi F, Benetucci J, Mancini M, Yang R, Wirtz V, Percival L, Zhang J, Zhu L, Arikan D, Farajallah A, Nguyen BY, Leavitt R, McGrath D, Lataillade M, The Spartan Study Team. A nucleoside- and ritonavir-sparing regimen containing atazanavir plus raltegravir in antiretroviral treatment-naive HIV-infected patients: SPARTAN study results. HIV Clin Trials. 2012 May-Jun;13(3):119-30. doi: 10.1310/hct1303-119.
PubMed 22592092
Song I, Borland J, Chen S, Lou Y, Peppercorn A, Wajima T, Min S, Piscitelli SC. Effect of atazanavir and atazanavir/ritonavir on the pharmacokinetics of the next-generation HIV integrase inhibitor, S/GSK1349572. Br J Clin Pharmacol. 2011 Jul;72(1):103-8. doi: 10.1111/j.1365-2125.2011.03947.x.
PubMed 21342217
Molina JM, Lamarca A, Andrade-Villanueva J, Clotet B, Clumeck N, Liu YP, Zhong L, Margot N, Cheng AK, Chuck SL; Study 145 Team. Efficacy and safety of once daily elvitegravir versus twice daily raltegravir in treatment-experienced patients with HIV-1 receiving a ritonavir-boosted protease inhibitor: randomised, double-blind, phase 3, non-inferiority study. Lancet Infect Dis. 2012 Jan;12(1):27-35. doi: 10.1016/S1473-3099(11)70249-3. Epub 2011 Oct 18.
PubMed 22015077
SECOND-LINE Study Group; Boyd MA, Kumarasamy N, Moore CL, Nwizu C, Losso MH, Mohapi L, Martin A, Kerr S, Sohn AH, Teppler H, Van de Steen O, Molina JM, Emery S, Cooper DA. Ritonavir-boosted lopinavir plus nucleoside or nucleotide reverse transcriptase inhibitors versus ritonavir-boosted lopinavir plus raltegravir for treatment of HIV-1 infection in adults with virological failure of a standard first-line ART regimen (SECOND-LINE): a randomised, open-label, non-inferiority study. Lancet. 2013 Jun 15;381(9883):2091-9. doi: 10.1016/S0140-6736(13)61164-2.
PubMed 23769235
Cahn P, Pozniak AL, Mingrone H, Shuldyakov A, Brites C, Andrade-Villanueva JF, Richmond G, Buendia CB, Fourie J, Ramgopal M, Hagins D, Felizarta F, Madruga J, Reuter T, Newman T, Small CB, Lombaard J, Grinsztejn B, Dorey D, Underwood M, Griffith S, Min S; extended SAILING Study Team. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. 2013 Aug 24;382(9893):700-8. doi: 10.1016/S0140-6736(13)61221-0. Epub 2013 Jul 3.
PubMed 23830355
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV-1 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Phase II Study of a Nucleoside Sparing Regimen of Dolutegravir + Atazanavir/r in HIV-1 Infected Patients With Detectable Viremia (DOLATAV Study)
ClinicalTrials.gov ID: NCT02542852
Acronym / sponsor ID: Dolatav / Dolatav Study
Conditions: HIV-1 Infection
Keywords: HIV-1
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Castagna AntonellaUniversity, hospital or other
Collaborators: Bristol-Myers Squibb, ViiV Healthcare
Study start: Sep 2015
Primary completion: Jun 2016 (actual)
Study completion: Dec 2017 (actual)
First posted: 7 Sep 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design;

24-week prospective, single-arm, monocentric, open label, pilot study Participants will be seen at screening, baseline, day 8 and at week 4, 8, 12, 16, 24.

At each visit the following evaluations will be performed:

clinical assessment.
routine laboratory tests (hematological tests and clinical chemistry) including hemochromocytometric examination with leukocytic formula, creatinine, creatine kinase, transaminases, phosphorus, calcium, alkaline phosphatase, total and direct bilirubin, gammaGT, uric acid, lactate dehydrogenase, urine analysis, glucose, lipid profile, HIV-RNA and CD4 cell counts.

Additional blood samples will be collected at each visit for storage and further determinations.

During follow-up, at different timepoints, patients will additionally undergo:

HbA1c and fasting insulin levels and HOMA-IR determination (baseline, week 12, week 24)
Adherence assessment (questionnaire and/or pills counts) at week 4, 12 and 24.
ECG (baseline and week 24)

Protocol virologic failure is defined as

< 1 log10 decrease in plasma HIV-1 RNA by week 12, with subsequent confirmation, unless plasma HIV-RNA < 200 copies/ml OR
a confirmed rebound in plasma HIV-RNA levels ≥ 50 copies/ml after prior confirmed suppression to < 50 copies/ml OR a confirmed plasma increase in HIV-1 RNA levels > 1log10 copies/ml above the nadir value where nadir is ≥ 50 copies/ml OR
a plasma HIV-1 RNA level ≥ 50 copies/ml at week 24

Subjects who meet a protocol-defined virologic failure during follow-up will be discontinued from the study.

In subjects with plasma HIV-RNA < 50 copies/ml at week 24, the study treatment will be successively provided by Italian National Health system.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Open label single arm	Experimental	Drug: atazanavir 300 mg + ritonavir 100 mg + dolutegravir 50 mgIntroduction of treatment regimen with atazanavir 300mg qd + ritonavir 100mg qd + dolutegravir 50mg qd

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Subjects with age more than 18 years
Willing and able to provide informed consent
Failing a stable (at least 3 months) antiretroviral therapy (HIV-RNA more than 200 copies/ml)
Any CD4 cell count
Virus susceptible to atazanavir, defined as a genotypic mutation score inferior to 15 according to the HIV drug resistance database (Stanford University)

Key exclusion criteria (11 listed)

Active AIDS-defining condition at Screening
Serious illness requiring systemic treatment and/or hospitalization
Current use of immunomodulant or immunosuppressive drugs
Requirement for any concomitant medications that are prohibited with any study drugs (protocol section 3.6)
History or presence of hypersensitivity to any of the active substances or to the excipients

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
atazanavir 300 mg + ritonavir 100 mg + dolutegravir 50 mgAlso: Reyataz 300 mg + norvir 100 mg + tivicay 50 mgSwitch to single arm treatment atazanavir-ritonavir 300-100 mg + dolutegravir 50 mg therapy for 24 weeks	Drug	Open label single arm

Primary outcome

Primary endpoint - The proportion of patients with undetectable HIV RNA viral load ( < 50 copies/ml) at week 24
Time frame: 24 weeks
The proportion of patients with undetectable HIV RNA viral load ( < 50 copies/ml) at week 24.

9 secondary outcomes

proportion of patient with undetactable HIV RNA at week 4 (Virologic efficacy)
Time frame: 4 week
Change from baseline CD4 cell counts (Immunological efficacy)
Time frame: 4,8,12,16,24 weeks
Time to achieve undetectability (Virologic efficacy)
Time frame: Day 8, weeks 4,8,12,16,24
Occurrence of genotyping resistance mutations for PI and INSTI in isolates from patients with virological failure.
Time frame: 24 week
Atazanavir and Dolutegravir Ctrough (PK evaluation)
Time frame: Day 8, weeks 4,8,12,16,24
Proportion of patients with adverse events (safety and tolerability).
Time frame: Day 8, weeks 4,8,12,16,24
Changes in lipid, clearance creatinine and glycemic profile from baseline (safety and tolerability)
Time frame: weeks 4,8,12,16,24
Change in ECG parameters (safety and tolerability)
Time frame: 24 week
Adherence evaluation
Time frame: 8,12,16,24 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
Background: PubMed 23225901Eron 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.
Background: PubMed 24259658Rathbun RC, Lockhart SM, Miller MM, Liedtke MD. Dolutegravir, a second-generation integrase inhibitor for the treatment of HIV-1 infection. Ann Pharmacother. 2014 Mar;48(3):395-403. doi: 10.1177/1060028013513558. Epub 2013 Nov 19.
Background: PubMed 22592092Kozal MJ, Lupo S, DeJesus E, Molina JM, McDonald C, Raffi F, Benetucci J, Mancini M, Yang R, Wirtz V, Percival L, Zhang J, Zhu L, Arikan D, Farajallah A, Nguyen BY, Leavitt R, McGrath D, Lataillade M, The Spartan Study Team. A nucleoside- and ritonavir-sparing regimen containing atazanavir plus raltegravir in antiretroviral treatment-naive HIV-infected patients: SPARTAN study results. HIV Clin Trials. 2012 May-Jun;13(3):119-30. doi: 10.1310/hct1303-119.
Background: PubMed 21342217Song I, Borland J, Chen S, Lou Y, Peppercorn A, Wajima T, Min S, Piscitelli SC. Effect of atazanavir and atazanavir/ritonavir on the pharmacokinetics of the next-generation HIV integrase inhibitor, S/GSK1349572. Br J Clin Pharmacol. 2011 Jul;72(1):103-8. doi: 10.1111/j.1365-2125.2011.03947.x.
Background: PubMed 22015077Molina JM, Lamarca A, Andrade-Villanueva J, Clotet B, Clumeck N, Liu YP, Zhong L, Margot N, Cheng AK, Chuck SL; Study 145 Team. Efficacy and safety of once daily elvitegravir versus twice daily raltegravir in treatment-experienced patients with HIV-1 receiving a ritonavir-boosted protease inhibitor: randomised, double-blind, phase 3, non-inferiority study. Lancet Infect Dis. 2012 Jan;12(1):27-35. doi: 10.1016/S1473-3099(11)70249-3. Epub 2011 Oct 18.
Background: PubMed 23769235SECOND-LINE Study Group; Boyd MA, Kumarasamy N, Moore CL, Nwizu C, Losso MH, Mohapi L, Martin A, Kerr S, Sohn AH, Teppler H, Van de Steen O, Molina JM, Emery S, Cooper DA. Ritonavir-boosted lopinavir plus nucleoside or nucleotide reverse transcriptase inhibitors versus ritonavir-boosted lopinavir plus raltegravir for treatment of HIV-1 infection in adults with virological failure of a standard first-line ART regimen (SECOND-LINE): a randomised, open-label, non-inferiority study. Lancet. 2013 Jun 15;381(9883):2091-9. doi: 10.1016/S0140-6736(13)61164-2.
Results publication: PubMed 23830355Cahn P, Pozniak AL, Mingrone H, Shuldyakov A, Brites C, Andrade-Villanueva JF, Richmond G, Buendia CB, Fourie J, Ramgopal M, Hagins D, Felizarta F, Madruga J, Reuter T, Newman T, Small CB, Lombaard J, Grinsztejn B, Dorey D, Underwood M, Griffith S, Min S; extended SAILING Study Team. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. 2013 Aug 24;382(9893):700-8. doi: 10.1016/S0140-6736(13)61221-0. Epub 2013 Jul 3.
Results publication: PubMed 24446523Castagna 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.

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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.

Adriano Lazzarin, Prof principal investigator

Ospedale San Raffaele

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing atazanavir 300 mg + ritonavir 100 mg + dolutegravir 50 mg in people with HIV-1 Infection, run by Castagna Antonella at 1 site in Italy.

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 11 inclusion and 11 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Primary endpoint - The proportion of patients with undetectable HIV RNA viral load ( < 50 copies/ml) at week 24 (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 NCT02542852, which also lists 8 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 13 Feb 2024.