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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000151-10 | EudraCT Number |
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Phase IIa, open clinical trial, pilot, single arm and proof of concept.
Proof of concept trial evaluating safety and efficacy of treatment with Dolutegravir (DTG) + lamivudine (3TC) once daily in suppressed participants with history of previous treatment with 3TC or emtricitabine (FTC). Half of the participants will have history of failure with 3TC or FTC and M184V/I or K65R/E/N mutations in previous plasma genotypes, although to be eligible these mutations cannot be detectable at study entry in proviral DNA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dolutegravir (DTG) + Lamivudine (3TC) | Experimental | Eligible subjects will receive one 50 mg tablet of DTG plus 300 mg 3TC tablet orally once daily upto 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolutegravir (DTG) | Drug | DTG 50 mg tablet will be orally administered once daily with or without food upto 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with undetectable viral load (<50 copies / mL) at 48 weeks | - Efficacy: Proportion of patients with undetectable viral load (<50 copies / mL) at 48 weeks of follow-up, according to the FDA snapshot algorithm in the population "by intention to treat-exposed". The intention-to-treat population includes all patients who have received at least one dose of DTG and 3TC. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with virological failure at 24 weeks | Proportion of patients with viral load <50 copies/ml at week 24, according to the FDA snapshot algorithm in the population "by intention to treat-exposed". | Week 24 |
| Proportion of patients with virological failure at 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital 12 de Octubre | Madrid | 28041 | Spain | |||
| Hospital Universitario La Paz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36447613 | Derived | De Miguel Buckley R, Rial-Crestelo D, Montejano R, Pinto A, Jimenez-Gonzalez M, Lagarde M, Esteban-Cantos A, Aranguren-Rivas P, Cadinanos J, Bisbal O, Castro JM, Santacreu-Guerrero M, Bermejo-Plaza L, Moreno V, Hernando A, Martin-Carbonero L, Rubio R, Delgado R, Arribas JR, Pulido F; Antiretroviral Treatment Guided by Proviral Genotype (ART-PRO) Study Group. Long-term Evaluation of Residual Viremia in a Clinical Trial of Dolutegravir Plus Lamivudine as Maintenance Treatment for Participants With and Without Prior Lamivudine Resistance. Open Forum Infect Dis. 2022 Nov 8;9(11):ofac610. doi: 10.1093/ofid/ofac610. eCollection 2022 Nov. | |
| 32408111 |
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| ID | Term |
|---|---|
| C562325 | dolutegravir |
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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Single arm opened with Intervention Type of Drug: Dolutegravir (DTG) and Lamivudina (3TC)
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| Lamivudine (3TC) | Drug | Lamivudine will be dispensed as 300 mg white, diamond shaped, scored, film coated tablets. It will be orally administered once daily with or without food upto 48 weeks. |
|
|
Proportion of patients with virological failure at week 48 according to the FDA snapshot algorithm. |
| Week 48 |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence of adverse events and discontinuation of treatment due to toxicity or intolerance. | Since baseline visits to week 48 |
| Evaluation of the appearance of genotypic resistance mutations (1) | Incidence of genotypic resistance mutations in patients with virological failure at week 48. Description and frequency of genotypic resistance mutations. | Week 48 |
| Madrid |
| 28046 |
| Spain |
| Derived |
| De Miguel R, Rial-Crestelo D, Dominguez-Dominguez L, Montejano R, Esteban-Cantos A, Aranguren-Rivas P, Stella-Ascariz N, Bisbal O, Bermejo-Plaza L, Garcia-Alvarez M, Alejos B, Hernando A, Santacreu-Guerrero M, Cadinanos J, Mayoral M, Castro JM, Moreno V, Martin-Carbonero L, Delgado R, Rubio R, Pulido F, Arribas JR; ART-PRO, PI16/00837-PI16/00678 study group. Dolutegravir plus lamivudine for maintenance of HIV viral suppression in adults with and without historical resistance to lamivudine: 48-week results of a non-randomized, pilot clinical trial (ART-PRO). EBioMedicine. 2020 May;55:102779. doi: 10.1016/j.ebiom.2020.102779. Epub 2020 May 11. |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |