CompletedPhase 3

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

Spain33 participantsStarted 2018-05-02

Plain-language summary

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)

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Proportion of Patients With Therapeutic Failure

Timeframe: 48 weeks

Trial details

NCT IDNCT03311945

SponsorJudit Pich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-30

Results submitted2025-06-13

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