Last updated on August 2019

Dolutegravir and Darunavir Evaluation in Adults Failing Therapy

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: HIV infection
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. HIV-1 positive by licensed diagnostic test
  2. Aged 16 years of age (or minimum age as determined by local regulations or as legal requirements dictate)
  3. Failed first-line non-nucleoside reverse transcriptase inhibitor (NNRTI) + 2N(t)RTI combination therapy according to virological criteria, defined as at least two consecutive (7 days apart) pVL results >500 copies/mL after a minimum period of exposure to continuous NNRTI + 2N(t)RTI first-line therapy of 24 weeks (only the second pVL result needs to be within 45 days of randomisation)
  4. For women of child-bearing potential, willingness to use appropriate contraception
  5. Able to provide written informed consent

Exclusion Criteria:

  1. The following laboratory variables:
  2. absolute neutrophil count (ANC) <500 cells/L
  3. haemoglobin <7.0 g/dL
  4. platelet count <50,000 cells/L
  5. AST and/or ALT 5xULN OR ALT 3xULN and bilirubin 1.5xULN (with >35% direct bilirubin)
  6. Change in antiretroviral therapy within 12 weeks prior to randomisation
  7. Prior exposure to HIV protease inhibitors and/or HIV integrase inhibitors
  8. Patients with chronic viral hepatitis B infection defined by positive serum hepatitis B surface antigen
  9. Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy (INR >2.3), hypoalbuminemia (serum albumin <2.8g/dL), esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  10. Anticipated need for Hepatitis C virus (HCV) therapy during the study
  11. Subject has creatinine clearance of <50 mL/min via CKD-EPI equation
  12. Current use of rifabutin or rifampicin
  13. Use of any contraindicated medications (as specified by product information sheets)
  14. Intercurrent illness requiring hospitalization
  15. An active opportunistic disease not under adequate control in the opinion of the investigator
  16. Pregnant or nursing mothers
  17. Patients with current alcohol or illicit substance use that in the opinion of the investigator might adversely affect participation in the study
  18. Patients deemed unlikely by the investigator to be able to remain in follow-up for the protocol-defined period

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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