Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM

Judit Pich

Status and phase: Completed; Phase 3

Conditions: HIV-1-infection; HIV Infections; HIV Seropositivity

Treatments: Drug: Lamivudine; Drug: Raltegravir

Study type: Interventional

Funder types: Other

Identifiers

NCT03311945

2017-000986-60

RALAM-Roll Over

Details and patient eligibility

About

Phase 3b, single arm, single site simplification study of HIV-1 infected patients with virological suppression under the combination of Lamivudine (150 mg BID) plus Raltegravir (400 mg BID) switching to Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD): Roll-over study of the RALAM clinical trial (NCT02284035)

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients in the switch arm who have completed the 24-week follow-up of RALAM (NCT02284035) study and remain virologically suppressed (viral load <50 copies/mL) on dual therapy with lamivudine plus Raltegravir
• Patients who have signed informed consent to participate in the study.

Exclusion criteria

• Pregnancy, lactation, or planned pregnancy during the study period
• Any disease or history of disease which, in opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment
• Hepatitis B co-infection

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

33 participants in 1 patient group

Raltegravir + Lamivudine

Experimental group

Description:

Lamivudine (300 mg QD) plusRaltegravir (1200 mg QD)

Treatment:

Drug: Raltegravir

Drug: Lamivudine