A Phase 3 interventional study of Raltegravir and Lamivudine in HIV Infections, HIV-1-infection and HIV Seropositivity, sponsored by Judit Pich. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by Judit Pich · Phase 3, Interventional, and Treatment
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)
194 studies on the registry are indexed under HIV Seropositivity; 11 are open to participants now.
This study's enrollment of 33 is below the median of 105 across 114 interventional studies indexed under HIV Seropositivity.
Browse HIV Seropositivity studies →Judit Pich is the lead sponsor of 7 studies on the registry; none are open to participants now.
Compared within HIV Seropositivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is HIV Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lamivudine (300 mg QD) plusRaltegravir (1200 mg QD)
Drug: Raltegravir · Drug: Lamivudine
Raltegravir (1200 mg QD)
Lamivudine (300 mg QD)
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.
Time frame: 48 weeks
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
Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) at 48 weeks
Time frame: 48 weeks
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.
| Milestone | RAL+3TC |
|---|---|
| Started | 33 |
| Completed | 30 |
| Not completed | 3 |
| Withdrew: Adverse event | 2 |
| Withdrew: Lack of efficacy | 1 |
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.
| Participants | Raltegravir + Lamivudine |
|---|---|
| Patients with therapeutic failure | 3 |
| Patients without therapeutic failure | 30 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) at 48 weeks
Results for this outcome have not been posted.
Collected over 48 weeks. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Raltegravir + Lamivudine | 0/33 (0%) | 0/33 (0%) | 16/33 (48.5%) |
| Event | Raltegravir + Lamivudine |
|---|---|
| GastrointestinalGastrointestinal disorders | 9/33 |
| SystemicGeneral disorders | 8/33 |
| RespiratoryRespiratory, thoracic and mediastinal disorders | 4/33 |
| DermatologicalSkin and subcutaneous tissue disorders | 2/33 |
| GenitourinaryRenal and urinary disorders | 2/33 |
| MusculoskeletalMusculoskeletal and connective tissue disorders | 1/33 |
| EndocrineEndocrine disorders | 1/33 |
| InfectionsImmune system disorders | 1/33 |
| Age, Continuous(years) | Raltegravir + Lamivudine |
|---|---|
| Mean | 53.7 ± 12.1 |
| Sex: Female, Male(Participants) | Raltegravir + Lamivudine |
|---|---|
| Female | 7 |
| Male | 26 |
| Race (NIH/OMB)(Participants) | Raltegravir + Lamivudine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 31 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Mar 2021, 34 months.
Results were first posted in Jul 2025, 4 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Raltegravir · Lamivudine
Judit Pich