Trial Outcomes & Findings for 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 (NCT NCT03311945)

Results Overview

Proportion of patients that at least present one of the following events: virological failure, change in antirretroviral treatment for any reason, consent withdrawal, loss to follow-up or death.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

33 participants

Primary outcome timeframe

48 weeks

Results posted on

2025-07-18

Participant Flow

All trial subjects were recruited at a single site in Spain: Hospital Clínic de Barcelona. The subjects were patients in the switch arm who completed the 24-week follow-up of RALAM (NCT02284035) study and remained virologically suppressed (viral load \<50 copies/mL) on dual therapy with 3TC plus Raltegravir. Recruitment start period: 02-May-2018.

Selection and baseline will be done in the same visit. Performed at Week 0. During this visit, written informed consent was obtained from each patient, and demographic data, medical history, complete physical examination, and laboratory tests (including hematology, biochemistry, and plasma viral load) were performed to confirm eligibility.

Participant milestones

Participant milestones
Measure	RAL+3TC Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD)
Overall Study STARTED	33
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	RAL+3TC Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD)
Overall Study Adverse Event	2
Overall Study Lack of Efficacy	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Raltegravir + Lamivudine n=33 Participants Lamivudine (300 mg QD) plusRaltegravir (1200 mg QD)
Age, Continuous	53.7 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

Proportion of patients that at least present one of the following events: virological failure, change in antirretroviral treatment for any reason, consent withdrawal, loss to follow-up or death.

Outcome measures

Outcome measures
Measure	Raltegravir + Lamivudine n=33 Participants Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD)
Proportion of Patients With Therapeutic Failure Patients with therapeutic failure	3 Participants
Proportion of Patients With Therapeutic Failure Patients without therapeutic failure	30 Participants

SECONDARY outcome

Timeframe: 48 weeks

Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) at 48 weeks

Outcome measures

Outcome data not reported

Adverse Events

Raltegravir + Lamivudine

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Raltegravir + Lamivudine n=33 participants at risk Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD)
Gastrointestinal disorders Gastrointestinal	27.3% 9/33 • Number of events 9 • 48 weeks Adverse events were assessed systematically at each study visit through clinical evaluation, laboratory testing, and patient self-reporting. Investigators used open-ended questioning, physical examination, and review of laboratory results to detect AEs. Severity was graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events. All AEs were recorded in the case report form, including onset, duration, severity, causality, and outcome.
Respiratory, thoracic and mediastinal disorders Respiratory	12.1% 4/33 • Number of events 4 • 48 weeks Adverse events were assessed systematically at each study visit through clinical evaluation, laboratory testing, and patient self-reporting. Investigators used open-ended questioning, physical examination, and review of laboratory results to detect AEs. Severity was graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events. All AEs were recorded in the case report form, including onset, duration, severity, causality, and outcome.
Skin and subcutaneous tissue disorders Dermatological	6.1% 2/33 • Number of events 2 • 48 weeks Adverse events were assessed systematically at each study visit through clinical evaluation, laboratory testing, and patient self-reporting. Investigators used open-ended questioning, physical examination, and review of laboratory results to detect AEs. Severity was graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events. All AEs were recorded in the case report form, including onset, duration, severity, causality, and outcome.
Renal and urinary disorders Genitourinary	6.1% 2/33 • Number of events 2 • 48 weeks Adverse events were assessed systematically at each study visit through clinical evaluation, laboratory testing, and patient self-reporting. Investigators used open-ended questioning, physical examination, and review of laboratory results to detect AEs. Severity was graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events. All AEs were recorded in the case report form, including onset, duration, severity, causality, and outcome.
Musculoskeletal and connective tissue disorders Musculoskeletal	3.0% 1/33 • Number of events 1 • 48 weeks Adverse events were assessed systematically at each study visit through clinical evaluation, laboratory testing, and patient self-reporting. Investigators used open-ended questioning, physical examination, and review of laboratory results to detect AEs. Severity was graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events. All AEs were recorded in the case report form, including onset, duration, severity, causality, and outcome.
Endocrine disorders Endocrine	3.0% 1/33 • Number of events 1 • 48 weeks Adverse events were assessed systematically at each study visit through clinical evaluation, laboratory testing, and patient self-reporting. Investigators used open-ended questioning, physical examination, and review of laboratory results to detect AEs. Severity was graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events. All AEs were recorded in the case report form, including onset, duration, severity, causality, and outcome.
Immune system disorders Infections	3.0% 1/33 • Number of events 1 • 48 weeks Adverse events were assessed systematically at each study visit through clinical evaluation, laboratory testing, and patient self-reporting. Investigators used open-ended questioning, physical examination, and review of laboratory results to detect AEs. Severity was graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events. All AEs were recorded in the case report form, including onset, duration, severity, causality, and outcome.
General disorders Systemic	24.2% 8/33 • Number of events 8 • 48 weeks Adverse events were assessed systematically at each study visit through clinical evaluation, laboratory testing, and patient self-reporting. Investigators used open-ended questioning, physical examination, and review of laboratory results to detect AEs. Severity was graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events. All AEs were recorded in the case report form, including onset, duration, severity, causality, and outcome.

Additional Information

Esteban Martínez

Hospital Clinic of Barcelona

Phone: +34 93 227 54 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place