HIV SeropositivityPhase 3NCT03333083
Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen
A Phase 3 study testing Raltegravir and Lamivudine in people with HIV Seropositivity and HIV Infections, run by Judit Pich at 1 site in Spain.
Trial summary
Phase 3b, single arm, simplification study with dual therapy including Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Seropositivity, HIV Infections, HIV-1-infection
- What is being tested?
- Raltegravir and Lamivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSpain
- Study dates
- 3 May 2018to 25 Jun 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Eligible patients will be males or females at least 18 years of age. Women of childbearing potential must have a negative pregnancy test within 10 days prior to randomization into the study.
- Patients seropositive for HIV-1 using standard diagnostic criteria.
- Patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen
- Patients virologically suppressed during at least 12 months prior to inclusion (viral load <50 copies/mL).
- Patients who have signed informed consent to participate in the study.
Who cannot join
- Pregnancy, lactation, or planned pregnancy during the study period.
- Previous failure to an integrase inhibitor-containing regimen.
- Previous failure to a Lamivudine or Emtricitabine-containing regimen.
- Resistance mutations to Lamivudine or integrase inhibitor if any resistance test had been previously performed.
- Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment.
- Chronic hepatitis B.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clínic i Provincial de Barcelona
Barcelona, Barcelona, 08036
About this study
Official title: Phase 3b, Single Arm, Simplification Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen. (RALAM-II Study)
Phase 3b, single arm, simplification study with dual therapy including Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen.
- Conditions
- HIV Seropositivity, HIV Infections, HIV-1-infection
- Being tested
- Raltegravir, Lamivudine
- Keywords
- Lamivudine, Raltegravir
- Medical subject headings
- HIV Seropositivity, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltegravirDrug
Raltegravir (1200 mg once a day)
LamivudineDrug
Lamivudine (300 mg once a day)
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir + Lamivudine | Experimental | Not described Receives: Drug: Raltegravir; Drug: Lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic failure
therapeutic failure at week 48, includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death
Measured: 48 weeks
Secondary outcomes (34)
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was inconenience
Changes in quality of life calculated by EQ-5D-5L if reason of switch was inconvenience
Measured: 48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was neurological toxicity
Changes on Pittsburgh Sleep Quality Index for neurological toxicity
Measured: 48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity
Changes on plasma lipids cholesterol LDL
Measured: 48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity
Changes on plasma lipids cholesterol HDL
Measured: 48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity
Changes on plasma lipids triglycerides
Measured: 48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was skeletal toxicity
Changes on dual energy x-ray absorptiometry bone density
Measured: 48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was digestive toxicity
Apperance of any adverse event that resolve their digestive toxicity: as diarrhea or digestive discomfort
Measured: 48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was drug-drug interactions
Proportion of drug-drug interaction with antirretroviral treatment
Measured: 48 weeks
Therapeutic failure
Measured: 24 weeks
Virological failure
Defined as two consecutive measurements of plasma viral load above 50 copies/ml
Measured: 24 weeks
Virological failure
Defined as two consecutive measurements of plasma viral load above 50 copies/ml
Measured: 48 weeks
Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL)
Measured: 48 weeks
Changes from baseline in cholesterol total
Measured: 24 weeks
Changes from baseline in HDL
Measured: 24 weeks
Changes from baseline in triglycerides
Measured: 24 weeks
Changes from baseline in insulin resistance (HOMA-IR)
Measured: 24 weeks
Changes from baseline in cholesterol LDL
Measured: 24 weeks
Changes from baseline in cholesterol LDL
Measured: 48 weeks
Changes from baseline in cholesterol total
Measured: 48 weeks
Changes from baseline in cholesterol HDL
Measured: 48 weeks
Changes from baseline in triglycerides
Measured: 48 weeks
Changes from baseline in and insulin resistance (HOMA-IR)
Measured: 48 weeks
Changes from baseline in body fat composition
Measured: 48 weeks
Changes from baseline in immune activation markers including CD38
Measured: 48 weeks
Changes from baseline in immune activation markers including HLA-DR
Measured: 48 weeks
Changes from baseline in biomarkers of inflammation IL-6,
Measured: 48 weeks
Changes from baseline in biomarkers of inflammation high sensitivity C-reactive protein
Measured: 48 weeks
Changes from baseline in biomarkers of mononuclear activation SD-14
Measured: 48 weeks
Changes from baseline in biomarkers of mononuclear activation SD-163
Measured: 48 weeks
Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index)
Measured: 24 weeks
Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index)
Measured: 48 weeks
Change from baseline in EQ-5D-5L
Measured: 24 weeks
Change from baseline in EQ-5D-5L
Measured: 48 weeks
Incidence of adverse events
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 posted6 Nov 2017
- Study start3 May 2018
- Primary completion25 Jun 2020
- Study completion25 Jun 2020
Why it stopped: The reason for the premature termination was the failure to reach the required number of participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeropositivityStudies 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
- 17 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
- NCT03333083
- Sponsor's protocol ID
- RALAM-II
- Other IDs
- 2017-000985-31, 2017
- Status last verified
- May 2025
- First submitted
- 29 Sep 2017
- Last updated
- 18 May 2025
- Results posted
- No
- 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 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3b, Single Arm, Simplification Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen. (RALAM-II Study)
- ClinicalTrials.gov ID
- NCT03333083
- Acronym / sponsor ID
- RALAM-II
- Conditions
- HIV Seropositivity, HIV Infections, HIV-1-infection
- Keywords
- Lamivudine, Raltegravir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The reason for the premature termination was the failure to reach the required number of participants.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Judit PichUniversity, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica
- Study start
- 3 May 2018 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
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, simplification study with dual therapy including Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen.
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: Lamivudine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eligible patients will be males or females at least 18 years of age. Women of childbearing potential must have a negative pregnancy test within 10 days prior to randomization into the study.
- Patients seropositive for HIV-1 using standard diagnostic criteria.
- Patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen
- Patients virologically suppressed during at least 12 months prior to inclusion (viral load <50 copies/mL).
- Patients who have signed informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Pregnancy, lactation, or planned pregnancy during the study period.
- Previous failure to an integrase inhibitor-containing regimen.
- Previous failure to a Lamivudine or Emtricitabine-containing regimen.
- Resistance mutations to Lamivudine or integrase inhibitor if any resistance test had been previously performed.
- Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment.
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 once a day) | Drug | Raltegravir + Lamivudine |
| LamivudineLamivudine (300 mg once a day) | Drug | Raltegravir + Lamivudine |
Primary outcome
Therapeutic failure
Time frame: 48 weeks
therapeutic failure at week 48, includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death
34 secondary outcomes
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was inconenience
Time frame: 48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was neurological toxicity
Time frame: 48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity
Time frame: 48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity
Time frame: 48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was cardiovascular toxicity or co-morbidity
Time frame: 48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was skeletal toxicity
Time frame: 48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was digestive toxicity
Time frame: 48 weeks
Change from baseline in the reason of change of the antiretroviral treatment in those patients the reason of change was drug-drug interactions
Time frame: 48 weeks
Therapeutic failure
Time frame: 24 weeks
Virological failure
Time frame: 24 weeks
Virological failure
Time frame: 48 weeks
Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL)
Time frame: 48 weeks
Changes from baseline in cholesterol total
Time frame: 24 weeks
Changes from baseline in 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
Changes from baseline in cholesterol LDL
Time frame: 24 weeks
Changes from baseline in cholesterol LDL
Time frame: 48 weeks
Changes from baseline in cholesterol total
Time frame: 48 weeks
Changes from baseline in cholesterol HDL
Time frame: 48 weeks
Changes from baseline in triglycerides
Time frame: 48 weeks
Changes from baseline in and insulin resistance (HOMA-IR)
Time frame: 48 weeks
Changes from baseline in body fat composition
Time frame: 48 weeks
Changes from baseline in immune activation markers including CD38
Time frame: 48 weeks
Changes from baseline in immune activation markers including HLA-DR
Time frame: 48 weeks
Changes from baseline in biomarkers of inflammation IL-6,
Time frame: 48 weeks
Changes from baseline in biomarkers of inflammation high sensitivity C-reactive protein
Time frame: 48 weeks
Changes from baseline in biomarkers of mononuclear activation SD-14
Time frame: 48 weeks
Changes from baseline in biomarkers of mononuclear activation SD-163
Time frame: 48 weeks
Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index)
Time frame: 24 weeks
Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index)
Time frame: 48 weeks
Change from baseline in EQ-5D-5L
Time frame: 24 weeks
Change from baseline in EQ-5D-5L
Time frame: 48 weeks
Incidence of adverse events
Time frame: 48 weeks
Results and safety
The study was stopped early (reason given: The reason for the premature termination was the failure to reach the required number of participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- 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 Seropositivity and HIV Infections, 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 18 May 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?
The study was stopped early (reason given: The reason for the premature termination was the failure to reach the required number of participants.). Results are not available in the source record.
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?
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 May 2025.