Randomized study in patients with chronic HIV infection.

Comparative, randomized, open study to evaluate maintenance with Darunavir/ritonavir once daily plus Lamivudine once daily versus continuing Darunavir/ritonavir once-daily plus Tenofovir/Emtricitabine (or Abacavir/Lamivudine) in HIV-infected subjects with undetectable plasma HIV viremia for at least six months.DUAL Study. - DUAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000515-14-ES

Enrollment

Unknown

Registered

2014-04-04

Start date

2014-06-26

Completion date

Unknown

Last updated

2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV chronic infection MedDRA version: 17.0 Level: LLT Classification code 10001509 Term: AIDS System Organ Class: 100000004862

Interventions

Product Name: Lamivudina Pharmaceutical Form: Tablet INN or Proposed INN: LAMIVUDINE CAS Number: 134678-17-4 Trade Name: PREZISTA Product Name: PREZISTA Pharmaceutical Form: Tablet Trade Name: PREZI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Consent to participate in the study, signing and dating the informed consent. 2. HIV patients > 18 years old. 3. Receiving DRV/r qd + TDF/FTC (or ABC/3TC) for at least 4 weeks. 4. Plasma HIV RNA =65 years) yes F.1.3.1 Number of subjects for this age range 256

Exclusion criteria

Exclusion criteria: 1. HIV pregnant or breastfeeding women. 2. Evidence of resistance to 3TC (any previous genotype with M184V/I mutation) and/or Darunavir (poblational genotype with demonstration of any of these mutations: V11I, V32I, L33F, I47V, I50V, I54L/M, G73S, T74P, L76V, I84V, L89V). 3. History of virologic failure (two consecutive viral loads of 200 cop/mL) while the patient was receiving 3TC or FTC, with the following exceptions: - Exclusion criteria will not be considered if the genotype performed in the moment of the virologic failure does not demonstrate resistance to 3TC and Darunavir (see exclusion criteria 1). - Exclusion criteria will not be considered in absence of genotype if after the episode a viral load or = 1.5 times upper limit. 10. Any analytical or clinical event that could jeopardize the patient's safety.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare safety and efficacy of the dual combination DRV/r qd + 3TC qd versus triple therapy with DRV/r qd + TDF/FTC (or ABC/3TC) in HIV-infected patients who have maintained at least six months of viral suppression while receiving triple therapy with DRV/r qd + TDF/FTC (or ABC/3TC).;Secondary Objective: To evaluate the safety and tolerability of the dual and triple combinations. To evaluate the incidence and type of resistance mutations in patients suffering virologic failure.;Primary end point(s): Proportion of patients with HIV-RNA levels below 50 HIV-RNA copies/ml by intention to treat analysis (FDA snapshot algorithm) at week 48.;Timepoint(s) of evaluation of this end point: 48 weeks	—

Measure

Time frame

Main Objective: To compare safety and efficacy of the dual combination DRV/r qd + 3TC qd versus triple therapy with DRV/r qd + TDF/FTC (or ABC/3TC) in HIV-infected patients who have maintained at least six months of viral suppression while receiving triple therapy with DRV/r qd + TDF/FTC (or ABC/3TC).;Secondary Objective: To evaluate the safety and tolerability of the dual and triple combinations. To evaluate the incidence and type of resistance mutations in patients suffering virologic failure.;Primary end point(s): Proportion of patients with HIV-RNA levels below 50 HIV-RNA copies/ml by intention to treat analysis (FDA snapshot algorithm) at week 48.;Timepoint(s) of evaluation of this end point: 48 weeks

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 24 weeks 48 weeks;Secondary end point(s): 1. Proportion of patients with HIV-RNA levels below 50 HIV-RNA copies/ml by intention to treat analysis (FDA snapshot algorithm) at week 24 2. Proportion of patients with HIV-RNA levels below 200 HIV-RNA copies/ml by intention to treat analysis (FDA snapshot algorithm) at week 48 3. Proportion of patients with virologic failure at week 48. 4. Percentage of patients with resistance development at week 48 5. Median changes in CD4 cell counts 6. Incidence of adverse events and incidence of drug discontinuation due to toxicity or intolerance. 7. Median changes in triglycerides, total, LDL- and HDL-cholesterol 8. Changes in eGFR 9. Changes in proportion of patients with renal tubular dysfunction 10. Proportion of resistance genotypic mutations in patients showing virologic failure at week 48. 11. Description and frequency of resistance genotypic mutations.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 24 weeks 48 weeks;Secondary end point(s): 1. Proportion of patients with HIV-RNA levels below 50 HIV-RNA copies/ml by intention to treat analysis (FDA snapshot algorithm) at week 24 2. Proportion of patients with HIV-RNA levels below 200 HIV-RNA copies/ml by intention to treat analysis (FDA snapshot algorithm) at week 48 3. Proportion of patients with virologic failure at week 48. 4. Percentage of patients with resistance development at week 48 5. Median changes in CD4 cell counts 6. Incidence of adverse events and incidence of drug discontinuation due to toxicity or intolerance. 7. Median changes in triglycerides, total, LDL- and HDL-cholesterol 8. Changes in eGFR 9. Changes in proportion of patients with renal tubular dysfunction 10. Proportion of resistance genotypic mutations in patients showing virologic failure at week 48. 11. Description and frequency of resistance genotypic mutations.

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Countries

Spain

Contacts

Public ContactInvestigación Científica

Fundación SEIMC-GESIDA

hesteban@f-sg.com0034915568025

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026