Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir (VIKING-4)

Study Status

Open to Enrollment

Study Description

This clinical trial is for HIV-positive men and women who are taking HIV medications, including at least one integrase inhibitor (raltegravir or elvitegravir), that have stopped working because the virus has become resistant to the medication.

The purpose of this study is to test how well the experimental drug dolutegravir (DTG) works in treating HIV when given after raltegravir or elvitegravir have stopped working. Dolutegravir is a new drug to treat HIV which works the same way as the other integrase inhibitors and has been shown to be effective in some people for whom raltegravir or elvitegravir are no longer effective.

The study has 2 phases:

  • Phase 1: During the first 7 days of the study, participants will be randomly assigned to receive either dolutegravir twice daily or a placebo twice daily. A placebo is a pill that looks like dolutegravir but does not contain medication.
  • Phase 2: At the Day 8 visit and onward, all participants will receive dolutegravir twice daily; there is no placebo in Phase 2. The study physician will also choose other medicines to treat HIV based on results of a participant’s resistance test conducted at the screening visit.

Participants will continue taking dolutegravir plus the medication chosen by the physician for up to 48 weeks, and possibly longer if the treatment is beneficial for the participant.

For the convenience of our study participants, we have 2 locations:

Chelsea: 119 West 24th Street

Upper East Side/East 68th Street: Baker 24 at NewYork-Presbyterian/Weill Cornell Medical Center

Click here to follow Cornell HIV Clinical Trials on Facebook

Disease Status and/or Stage

Integrase Inhibitor Resistant

Sponsor

ViiV Healthcare

Key Eligibility

  • Men and women age 18 and older
  • HIV-positive
  • Currently taking antiretroviral therapy including an integrase inhibitor
  • Genotype resistance to raltegravir or elvitegravir (confirmed at screening)
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Timothy Wilkin, MD

Contact

Healthy Volunteers

healthy_volunteers.jpg

As a healthy volunteer in a clinical trial you may make a significant contribution to the discovery of medical knowledge and new treatments that could impact people around the world.
Click here for studies seeking healthy volunteers.

Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

Top of page