Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virolog… (NCT03333083) | Clinical Trial Compass
TerminatedPhase 3
Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen
Stopped: The reason for the premature termination was the failure to reach the required number of participants.
Spain17 participantsStarted 2018-05-03
Plain-language summary
Phase 3b, single arm, simplification study with dual therapy including Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Eligible patients will be 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.
* Patients seropositive for HIV-1 using standard diagnostic criteria.
* Patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen
* Patients virologically suppressed during at least 12 months prior to inclusion (viral load \<50 copies/mL).
* Patients who have signed informed consent to participate in the study.
Exclusion Criteria:
* Pregnancy, lactation, or planned pregnancy during the study period.
* Previous failure to an integrase inhibitor-containing regimen.
* Previous failure to a Lamivudine or Emtricitabine-containing regimen.
* Resistance mutations to Lamivudine or integrase inhibitor if any resistance test had been previously performed.
* 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.
* Chronic hepatitis B.