NCT03311945

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_3 hiv-infections

Timeline
Completed

Started May 2018

Typical duration for phase_3 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

May 2, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

July 18, 2025

Completed
Last Updated

July 18, 2025

Status Verified

June 1, 2025

Enrollment Period

2.9 years

First QC Date

September 29, 2017

Results QC Date

June 13, 2025

Last Update Submit

June 30, 2025

Conditions

HIV InfectionsHIV-1-infectionHIV Seropositivity

Keywords

RaltegravirLamivudine

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients With Therapeutic Failure

    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.

    48 weeks

Secondary Outcomes (19)

  • Change From Baseline in Peripheral Mononuclear Blood Cells HIV-1 Reservoir

    48 weeks

  • Changes From Baseline in Cholesterol Total

    24 weeks

  • Changes From Baseline in Cholesterol LDL

    24 weeks

  • Changes From Baseline in Cholesterol HDL

    24 weeks

  • Changes From Baseline in Triglycerides

    24 weeks

  • +14 more secondary outcomes

Study Arms (1)

Raltegravir + Lamivudine

EXPERIMENTAL

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

Drug: RaltegravirDrug: Lamivudine

Interventions

RaltegravirDRUG

Raltegravir (1200 mg QD)

Raltegravir + Lamivudine
LamivudineDRUG

Lamivudine (300 mg QD)

Raltegravir + Lamivudine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

HIV InfectionsHIV Seropositivity

Interventions

Raltegravir PotassiumLamivudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Results Point of Contact

Title
Esteban Martínez
Organization
Hospital Clinic of Barcelona
estebanm@clinic.cat
+34 93 227 54 00

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Manager

Study Record Dates

First Submitted

September 29, 2017

First Posted

October 17, 2017

Study Start

May 2, 2018

Primary Completion

March 30, 2021

Study Completion

November 30, 2022

Last Updated

July 18, 2025

Results First Posted

July 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)