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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-001198-25 |
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| Name | Class |
|---|---|
| Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | OTHER |
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To evaluate the proportion of patients with virological failure after 48 weeks of treatment with the combination of efavirenz 600 mg + lamivudine (3TC) 300 mg + abacavir 600 mg once daily as an antiretroviral simplification regimen.
Treatment simplification is a therapeutic strategy that allows patients with controlled viral replication to switch to an easier-to-take antiretroviral system to promote long-term adherence and thus maintain controlled viral load for longer, delaying the evolution of the HIV infection.
The combination of ABC+3TC+EFV is a potent and easy-to-take regimen (2 tablets once a day) that could be suitable for the simplification of antiretroviral treatment in patients with controlled viral load with a regimen that includes 2 NRTI taken twice daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | abacavir 600 mg + lamivudine (3TC) 300 mg in 1 tablet + efavirenz 600 mg 1/24h |
|
| B | No Intervention | efavirenz + 2 NUCS |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efavirenz | Drug | Efavirenz |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Viral load of HIV-1 at each visit with regard to the baseline visit. | At 12, 24, 36 and 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate immunological efficacy (changes in the CD4 and CD8 counts) of the combination studied over the follow-up period. | At 12, 24, 36 and 48 weeks | |
| To evaluate the tolerance and safety of the combination of abacavir+ lamivudine (in a single tablet) + efavirenz given once daily over 48-week treatment period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonaventura Clotet, MD, PhD | Lluita contra la Sida Foundation-HIV Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Germans Trias i Pujol Hospital | Badalona | Barcelona | 08916 | Spain | ||
| Hospital de la Vall d'Hebron |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C098320 | efavirenz |
| C492871 | abacavir, lamivudine drug combination |
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| Abacavir+lamivudine |
| Drug |
Abacavir+lamivudine |
|
|
| At 12, 24, 36 and 48 weeks |
| To evaluate treatment adherence (assessed by a self-reported questionnaire and with graduated satisfaction scales) and patient quality of life (assessed by means of the MOS-HIV questionnaire). | At 12, 24, 36 and 48 weeks |
| Barcelona |
| Barcelona |
| 08035 |
| Spain |
| Hospital de Mataró | Mataró | Barcelona | 08304 | Spain |
| Hospital Virgen de las Nieves | Granada | Granada | 18014 | Spain |
| Hospital de Aranzazu | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Hospital San Millan de Logroño | Logroño | La Rioja | 26001 | Spain |
| Hospital Arnau de Vilanova de Lleida | Lleida | Lleida | 25198 | Spain |
| Hospital Principe de Asturias | Alcalá de Henares | Madrid | 28005 | Spain |
| Hospital Severo Ochoa Leganés | Madrid | Madrid | 28911 | Spain |
| Hospital de Móstoles | Móstoles | Madrid | 28935 | Spain |
| Hospital Costa del Sol | Marbella | Málaga | 29600 | Spain |
| Hospital Cristal-Piñor | Ourense | Ourense | 32005 | Spain |
| Hospital Santa María Nai | Ourense | Ourense | 32005 | Spain |
| Hospital de Navarra | Pamplona | Pamplona | 31008 | Spain |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Santa Cruz de Tenerife | 38320 | Spain |
| Hospital General de Valencia | Valencia | Valencia | 46014 | Spain |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |