A Phase 3 interventional study of Raltegravir and Lamivudine in HIV Seropositivity, HIV Infections and HIV-1-infection, sponsored by Judit Pich. Terminated at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by Judit Pich · Phase 3, Interventional, and Treatment
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.
194 studies on the registry are indexed under HIV Seropositivity; 11 are open to participants now.
This study's enrollment of 17 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.
Counted across the registry records on this site, refreshed daily.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Raltegravir · Drug: Lamivudine
Raltegravir (1200 mg once a day)
Lamivudine (300 mg once a day)
Therapeutic failure
therapeutic failure at week 48, includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death
Time frame: 48 weeks
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
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
Changes on Pittsburgh Sleep Quality Index for 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
Changes on plasma lipids cholesterol LDL
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
Changes on plasma lipids cholesterol HDL
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
Changes on plasma lipids triglycerides
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
Changes on dual energy x-ray absorptiometry bone density
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
Apperance of any adverse event that resolve their digestive toxicity: as diarrhea or digestive discomfort
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
Proportion of drug-drug interaction with antirretroviral treatment
Time frame: 48 weeks
Therapeutic failure
Time frame: 24 weeks
Virological failure
Defined as two consecutive measurements of plasma viral load above 50 copies/ml
Time frame: 24 weeks
Virological failure
Defined as two consecutive measurements of plasma viral load above 50 copies/ml
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
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Jun 2020, 25 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 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