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Clinical Trials/NL-OMON42090
NL-OMON42090CompletedPhase 2

Pharmacokinetics, safety and efficacy of atazanavir /dolutegravir/lamivudine regimen as maintenance regimen in patients with intolerance and/or resistance to NRTIs, NNRTIs and RTV: a pilot study (PRADA II study) - PRADA II

niversitair Medisch Centrum Sint Radboud0 sites9 target enrollmentStarted: TBDLast updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
9

Study Overview

Brief Summary

Trial is onging in other countries

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • 1. HIV-infected as documented by positive HIV antibody test and confirmed by Western Blot.
  • 2. Subject is in need for a switch in maintenance regimen due to adverse effects, toxicities, simplification and/or resistance.
  • 3. Subject is at least 18 years of age at the day of screening.
  • 4. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
  • 5. HIV-1 RNA < 40 copies/mL for at least 6 months on antiretroviral therapy prior to inclusion.
  • 6. Subject has no documented resistance mutations to PIs, INSTIs or lamivudine.

Exclusion Criteria

  • 1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
  • 2. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
  • 3. Inability to understand the nature and extent of the trial and the procedures required.
  • 4. Pregnant female (as confirmed by an HCG test performed less than 3 weeks before the first dose) or breast-feeding female.
  • 5. Abnormal serum transaminases determined as levels being > 5 times upper limit of normal (see Appendix A for normal ranges of clinical laboratory values).
  • 6. Renal failure determined as an estimated Glomerular Filtration Rate (eGFR) < 50 ml/min (MDRD-based).
  • 7. Concomitant use of medications that interfere with atazanavir, dolutegravir or lamivudine pharmacokinetics: oxcarbamazepine, phenytoin, phenobarbital, carbamazepine, St. John*s wort, rifampicin, clarithromycin, H2 receptor antagonists, proton pump inhibitors, irinotecan, midazolam, triazolam, buprenorfine, aprepitant, modafinil, imatinib, co-trimoxazole, other antiretroviral drugs.
  • 8. Concomitant use of medications that are contraindicated for use with atazanavir, dolutegravir or lamivudine: alfuzosin, pimozide, quetiapine, kinidine, bepridil, simvastatin, atorvastatin, lovastatin, sildenafil (as for use in pulmonary arterial hypertension), cladribine.
  • 9. Active hepatobiliary or hepatic disease (including chronic hepatitis B or C infection).
  • 10. Alcohol abuse.

Investigators

Sponsor
niversitair Medisch Centrum Sint Radboud

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