A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen. (VIKING-3)

ViiV Healthcare

Status and phase

Completed

Phase 3

Conditions

Infection, Human Immunodeficiency Virus

Treatments

Drug: dolutegravir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01328041

112574

Details and patient eligibility

About

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.

Full 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.

Enrollment

183 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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
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