Pilotstudy to asses the pharmacokinetics, the efficacy and safety of the combination of atazanavir, dolutegravir and lamivudine in HIV-1 infected patients who experience side-effects, toxicities or resistance to other anti-HIV drugs.

Phase 1

Conditions: HIV
MedDRA version: 17.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2014-004488-19-NL

Lead Sponsor: Radboud University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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, me-tabolism 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 pharma-cokinetics: oxcarbamazepine, phenytoin, phenobarbital, carbamazepine, St. John’s wort, rifam-picin, clarithromycin, H2 receptor antagonists, proton pump inhibitors, irinotecan, midazolam, triazolam, co-trimoxazole, other antiretroviral drugs.
8.Concomitant use of medications that are contraindicated for use with atazanavir, dolutegravir or lamivudine: alfuzosin, dofetilide, 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.