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AIDSPhase 3RALAMNCT02284035

Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine

A Phase 3 study testing Raltegravir/3TC, EFV/TDF/FTC and ATV/r + TDF/FTC or DRV/r + TDF/FTC in people with AIDS, run by Juan A. Arnaiz at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A pilot 24-week open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of dual therapy with Raltegravir/Lamivudine combination when replacing standard combination therapy in HIV-infected patients with prolonged virological suppression Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
AIDS
What is being tested?
Raltegravir/3TC, EFV/TDF/FTC and ATV/r + TDF/FTC or DRV/r + TDF/FTC
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteSpain
Study dates
27 Sep 2015to 28 Feb 2017
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

  • 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 virologically suppressed during at least 12 months prior to inclusion (viral load <50 copies/mL).
  • Patients on combination antiretroviral therapy (at least 2 antiretroviral drugs) for at least 12 months before being randomized in this study.
  • Patients who are clinically stable in the opinion of the investigator at study entry (clinical status and chronic medication must not have not been modified at least 14 days prior to randomization).
  • 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 3TC or FTC-containing regimen.
  • Resistance mutations to 3TC 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 Clinic

    Barcelona, 08036

Other trials in Spain

About this study

Official title: Pilot 24week Clinical Trial to Assess the Safety, Tolerability and Efficacy of Dual Therapy With Raltegravir/Lamivudine Combination, Replacing Standard Combination Therapy in HIV-infected Pts With Prolonged Virological Suppression.

A pilot 24-week open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of dual therapy with Raltegravir/Lamivudine combination when replacing standard combination therapy in HIV-infected patients with prolonged virological suppression

Conditions
AIDS
Being tested
Raltegravir/3TC, EFV/TDF/FTC, ATV/r + TDF/FTC or DRV/r + TDF/FTC, DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC, EFV plus ABC/3TC or RPV/TDF/FTC
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Raltegravir/3TCDrug

    MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.

  • EFV/TDF/FTCDrug

    Also called NNRTI-Based Regimen

    standard combination therapy

  • ATV/r + TDF/FTC or DRV/r + TDF/FTCDrug

    Also called PI-Based Regimens

  • DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTCDrug

    Also called INSTI-Based Regimens

  • EFV plus ABC/3TC or RPV/TDF/FTCDrug

    Also called NNRTI-Based Regimens

  • ATV/r plus ABC/3TCDrug

    Also called PI-Based Regimen

  • DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTCDrug

    Also called PI-Based Regimens

  • RAL plus ABC/3TCDrug

    Also called INSTI-Based Regimen

  • Other ART regimensDrug

Study groups in NCT02284035
Study groupRoleWhat they receive
Group 1 Raltegravir / 3TC (MK0518BExperimentalRaltegravir / 3TC (MK0518B ) (50 patients)
Receives: Drug: Raltegravir/3TC
Group 2 standard combination therapyActive comparatorNNRTI-Based Regimen: • EFV/TDF/FTC PI-Based Regimens: ATV/r + TDF/FTC or DRV/r + TDF/FTC INSTI-Based Regimens: DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC NNRTI-Based Regimens: EFV plus ABC/3TC or RPV/TDF/FTC PI-Based Regimen: ATV/r plus ABC/3TC PI-Based Regimens: DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC INSTI-Based Regimen: RAL plus ABC/3TC And other ART regimens
Receives: Drug: EFV/TDF/FTC; Drug: ATV/r + TDF/FTC or DRV/r + TDF/FTC; Drug: DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC; Drug: EFV plus ABC/3TC or RPV/TDF/FTC; Drug: ATV/r plus ABC/3TC; Drug: DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC; Drug: RAL plus ABC/3TC; Drug: Other ART regimens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients Free of Therapeutic Failure

    Proportion of patients free of therapeutic failure at week 24. Therapeutic failure includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death

    Measured: 24 weeks

Secondary outcomes (20)

  1. Efficacy in Virological Suppression Assessed With Ultrasensitive HIV-1 RNA Detection (Limit of Detection 1 Copy/mL)

    Measured: 24 weeks

  2. Changes in Peripheral Mononuclear Blood Cells HIV-1 Reservoir

    Measured: 24 weeks

  3. Changes in Insulin Resistance (HOMA-IR)

    Composite measure

    Measured: 24 weeks

  4. Changes in Body Fat Composition

    Composite measure

    Measured: 24 weeks

  5. Changes in Plasma 25-OH Vitamin D Levels

    Measured: 24 weeks

  6. Changes in Estimated Glomerular Filtration Rate (CKD-EPI)

    Composite measure

    Measured: 24 weeks

  7. Changes in CD38

    Measured: 24 weeks

  8. Changes in IL-6

    Measured: 24 weeks

  9. Changes in Sleep Quality (Pittsburgh Sleep Quality Index)

    The Pittsburgh Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven áreas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month.

    The posible range of the scale is from 0 to 21 points. The greater the score the poorest is the sleep quality.

    Measured: 24 weeks

  10. Changes in Adherence in Both Treatment Arms (Morisky-Green Test)

    Patients were asked to complete the Morisky-Green questionnaire:

    Some people forget to take their medication as prescribed. How often does it happen to you? (Always/often/sometimes/rarely/never) Some people forget some taking of the medication or change the prescribed schedule / take to adapt it to their own needs. How often do you do it? (Always/often/sometimes/rarely/never) Some people stop taking their medications as prescribed when they feel better. How often do you do it? (Always/often/sometimes/rarely/never) Some people stop taking their medications as prescribed when they feel worse. How often do you do it? (Always/often/sometimes/rarely/never)

    Only if patients answered never to each four questions, they were considered adherent; if not, non adherent.

    Measured: 24 weeks

  11. Changes in Total Cholesterol

    Measured: 24 weeks

  12. Changes in HDL Cholesterol

    Measured: 24 weeks

  13. Changes in LDL Cholesterol

    Measured: 24 weeks

  14. Changes in Triglycerides

    Measured: 24 weeks

  15. Changes in Bone Mineral Density

    DEXA

    Measured: 24 weeks

  16. Changes in Urine Beta-2-microglobulin/Creatinine Ratio

    Measured: 24 weeks

  17. Changes in HLA-DR

    Measured: 24 weeks

  18. Changes in High Sensitivity C-reactive Protein

    Measured: 24 weeks

  19. Changes in Mononuclear Activation SD-14

    Measured: 24 weeks

  20. Changes in Mononuclear Activation SD-163

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2014 (estimated)
  2. Study start27 Sep 2015
  3. Primary completion28 Feb 2017
  4. Study completion28 Feb 2017

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02284035
Sponsor's protocol ID
RALAM
Other IDs
2014-003142-27, 2014
Acronym
RALAM
Status last verified
Jul 2025
First submitted
28 Oct 2014
Last updated
20 Jul 2025
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Raltegravir/3TC, EFV/TDF/FTC and ATV/r + TDF/FTC or DRV/r + TDF/FTC in people with AIDS, run by Juan A. Arnaiz 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 6 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: finished, as of the sponsor's last update on 20 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 20 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 Free of Therapeutic Failure (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02284035.

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 20 Jul 2025.

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