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Completed

NCT Number: NCT03311945

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

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)

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases HIV Seropositivity HIV-1-infection Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

raltegravir

Drug

Raltegravir (1200 mg QD)

Lamivudine

Drug

Lamivudine (300 mg QD)

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 48 weeks

  2. Changes From Baseline in Cholesterol Total

    Time frame: 24 weeks

  3. Changes From Baseline in Cholesterol LDL

    Time frame: 24 weeks

  4. Changes From Baseline in Cholesterol HDL

    Time frame: 24 weeks

  5. Changes From Baseline in Triglycerides

    Time frame: 24 weeks

  6. Changes From Baseline in Insulin Resistance (HOMA-IR)

    Time frame: 24 weeks

  7. Change From Baseline in Lumbar and Femoral Bone Mineral Density

    Time frame: 48 weeks

  8. Change From Baseline in Plasma 25-OH Vitamin D Levels

    Time frame: 48 weeks

  9. Change From Baseline in Urine Beta-2-microglobulin

    Time frame: 48 weeks

  10. Change From Baseline in Estimated Glomerular Filtration Rate (Chronic Kidney Disease Epidemiology CollaborationI)

    Time frame: 48 weeks

  11. Change From Baseline in Urine Protein/Creatinine Ratio

    Time frame: 48 weeks

  12. Changes From Baseline in Biomarkers of Inflammation IL-6

    Time frame: 48 weeks

  13. Changes From Baseline in Biomarker of Mononuclear Activation SD-163

    Time frame: 48 weeks

  14. Changes From Baseline in Biomarker of Mononuclear Activation SD-14

    Time frame: 48 weeks

  15. Changes From Baseline in Biomarker of Inflammation High Sensitivity C-reactive Protein

    Time frame: 48 weeks

  16. Changes From Baseline in Sleep Quality (Pittsburgh Sleep Quality Index) at

    Time frame: 48 weeks

  17. Change From Baseline in EQ-5D-5L

    Time frame: 48 weeks

  18. Incidence of Adverse Events

    Time frame: 48 weeks

  19. Viral Load

    Time frame: 48 weeks

    Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) at 48 weeks

Sponsors and collaborators

Lead sponsor

Judit Pich

Other

Collaborators

  • Fundacion Clinic per a la Recerca Biomédica

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Oct 17, 2017
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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