HIV InfectionsPhase 3NCT03311945
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
A Phase 3 study testing Raltegravir and Lamivudine in people with HIV Infections and HIV-1-infection, run by Judit Pich at 1 site in Spain.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, HIV-1-infection, HIV Seropositivity
- What is being tested?
- Raltegravir and Lamivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 2 May 2018to 30 Nov 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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)
- Conditions
- HIV Infections, HIV-1-infection, HIV Seropositivity
- Being tested
- Raltegravir, Lamivudine
- Keywords
- Raltegravir, Lamivudine
- Medical subject headings
- HIV Infections, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltegravirDrug
Raltegravir (1200 mg QD)
LamivudineDrug
Lamivudine (300 mg QD)
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir + Lamivudine | Experimental | Lamivudine (300 mg QD) plusRaltegravir (1200 mg QD) Receives: Drug: Raltegravir; Drug: Lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks
Secondary outcomes (19)
Change From Baseline in Peripheral Mononuclear Blood Cells HIV-1 Reservoir
Measured: 48 weeks
Changes From Baseline in Cholesterol Total
Measured: 24 weeks
Changes From Baseline in Cholesterol LDL
Measured: 24 weeks
Changes From Baseline in Cholesterol HDL
Measured: 24 weeks
Changes From Baseline in Triglycerides
Measured: 24 weeks
Changes From Baseline in Insulin Resistance (HOMA-IR)
Measured: 24 weeks
Change From Baseline in Lumbar and Femoral Bone Mineral Density
Measured: 48 weeks
Change From Baseline in Plasma 25-OH Vitamin D Levels
Measured: 48 weeks
Change From Baseline in Urine Beta-2-microglobulin
Measured: 48 weeks
Change From Baseline in Estimated Glomerular Filtration Rate (Chronic Kidney Disease Epidemiology CollaborationI)
Measured: 48 weeks
Change From Baseline in Urine Protein/Creatinine Ratio
Measured: 48 weeks
Changes From Baseline in Biomarkers of Inflammation IL-6
Measured: 48 weeks
Changes From Baseline in Biomarker of Mononuclear Activation SD-163
Measured: 48 weeks
Changes From Baseline in Biomarker of Mononuclear Activation SD-14
Measured: 48 weeks
Changes From Baseline in Biomarker of Inflammation High Sensitivity C-reactive Protein
Measured: 48 weeks
Changes From Baseline in Sleep Quality (Pittsburgh Sleep Quality Index) at
Measured: 48 weeks
Change From Baseline in EQ-5D-5L
Measured: 48 weeks
Incidence of Adverse Events
Measured: 48 weeks
Viral Load
Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) at 48 weeks
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start2 May 2018
- Primary completion30 Mar 2021
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Judit Pich
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica
- Responsible party
- Sponsor-investigator, Judit Pich, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311945
- Sponsor's protocol ID
- RALAM-Roll Over
- Other IDs
- 2017-000986-60, 2017
- Status last verified
- Jun 2025
- First submitted
- 29 Sep 2017
- Last updated
- 18 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03311945
- Acronym / sponsor ID
- RALAM-Roll Over
- Conditions
- HIV Infections, HIV-1-infection, HIV Seropositivity
- Keywords
- Raltegravir, Lamivudine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Judit PichUniversity, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica
- Study start
- 2 May 2018 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Posted 18 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raltegravir + Lamivudine | Experimental | Drug: Raltegravir, Drug: LamivudineLamivudine (300 mg QD) plusRaltegravir (1200 mg QD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RaltegravirRaltegravir (1200 mg QD) | Drug | Raltegravir + Lamivudine |
| LamivudineLamivudine (300 mg QD) | Drug | Raltegravir + Lamivudine |
Primary outcome
Proportion of Patients With Therapeutic Failure
Time frame: 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.
19 secondary outcomes
Change From Baseline in Peripheral Mononuclear Blood Cells HIV-1 Reservoir
Time frame: 48 weeks
Changes From Baseline in Cholesterol Total
Time frame: 24 weeks
Changes From Baseline in Cholesterol LDL
Time frame: 24 weeks
Changes From Baseline in Cholesterol HDL
Time frame: 24 weeks
Changes From Baseline in Triglycerides
Time frame: 24 weeks
Changes From Baseline in Insulin Resistance (HOMA-IR)
Time frame: 24 weeks
Change From Baseline in Lumbar and Femoral Bone Mineral Density
Time frame: 48 weeks
Change From Baseline in Plasma 25-OH Vitamin D Levels
Time frame: 48 weeks
Change From Baseline in Urine Beta-2-microglobulin
Time frame: 48 weeks
Change From Baseline in Estimated Glomerular Filtration Rate (Chronic Kidney Disease Epidemiology CollaborationI)
Time frame: 48 weeks
Change From Baseline in Urine Protein/Creatinine Ratio
Time frame: 48 weeks
Changes From Baseline in Biomarkers of Inflammation IL-6
Time frame: 48 weeks
Changes From Baseline in Biomarker of Mononuclear Activation SD-163
Time frame: 48 weeks
Changes From Baseline in Biomarker of Mononuclear Activation SD-14
Time frame: 48 weeks
Changes From Baseline in Biomarker of Inflammation High Sensitivity C-reactive Protein
Time frame: 48 weeks
Changes From Baseline in Sleep Quality (Pittsburgh Sleep Quality Index) at
Time frame: 48 weeks
Change From Baseline in EQ-5D-5L
Time frame: 48 weeks
Incidence of Adverse Events
Time frame: 48 weeks
Viral Load
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Raltegravir and Lamivudine in people with HIV Infections and HIV-1-infection, run by Judit Pich at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Therapeutic Failure (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.