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

Judit Pich

Status and phase

Terminated

Phase 3

Conditions

HIV-1-infection

HIV Infections

HIV Seropositivity

Treatments

Drug: Raltegravir

Drug: Lamivudine

Study type

Interventional

Funder types

Other

Identifiers

NCT03333083

2017-000985-31

RALAM-II

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.