An open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of two dolutegravir-based simplification strategies in HIV-infected patients with prolonged virological suppression - DOLAM

FUNDACIÓ CLÍNIC PER A LA RECERCA BIOMÈDICA0 sites265 target enrollmentStarted: February 16, 2015Last updated: March 2, 2022

Conditions

Drugs

Trial Snapshot

No summary available.

•1.Males or females at least 18 years of age. Women of childbearing potential* must have a negative pregnancy test within 10 days prior to randomization into the study and commitment to use at least one of these birth control methods: male or female condom with or without spermicide, cap, diaphragm or sponge with or without spermicide, intrauterine device, bilateral tubal occlusion, vasectomized partner, sexual abstinence during the study.
•2.Seropositive for HIV-1 using standard diagnostic criteria.
•3.Virologicaly suppressed (<50 copies/mL in 2 or more consecutive determinations) during at least the 12 months prior to inclusion. Blips up to 200 copies/mL are permitted.
•4.On stable (for at least the previous 12 months) triple antiretroviral therapy based on protease inhibitors, non-nucleoside reverse transcriptase inhibitors, or integrase inhibitors.
•5.Clinically stable in the opinion of the investigator at the beginning of the study.
•6.Have signed informed consent to participate in the study.
•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 291
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Pregnancy, lactation, or planned pregnancy during the study period.
•2. Prior virological failure (? 50 copies/mL in 2 consecutive determinations or >500 copies/mL in one determination) to regimens containing 3TC/FTC or integrase inhibitors.
•3. Any mutation conferring resistance to 3TC/FTC or integrase inhibitors if genotypic testing had been previously performed.
•4. Nadir CD4 <200 cells/mm3.
•5. Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment.
•6. Chronic hepatitis B (HBsAg+) or anticipated need for Hepatitis C virus (HCV) therapy during the study.
•7. History or presence of allergy to the study drugs components.
•8. ALT =5 times the upper limit of normal (ULN) or ALT =3 x ULN and bilirubin = 1.5 x ULN at screening.

Sponsor

FUNDACIÓ CLÍNIC PER A LA RECERCA BIOMÈDICA