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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-001282-18 |
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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 therapeutic equivalence between the two arms of treatment in virological and immunological response after 48 weeks and to evaluate the presence of side effects during the follow-up period.
The efficacy of the highly active antiretroviral treatment (HAART) has been demonstrated in several clinical trials. Even so, a substantial proportion of patients do not manage to maintain correct viral suppression in daily clinical practice.
Adherence to HAART treatment is critical to obtain lasting viral suppression. Thus, factors that are related to adherence such as high pill load or takes, the complexity of the antiretroviral system, tolerability and food restrictions may have an effect on viral replication.
It has been demonstrated that simpler regimens with a scant number of tablets, without food restrictions and with a single take a day are safe, efficacious and that adherence improves.
The combination of abacavir 600 mg + lamivudine 300 mg QD in a single tablet is a novel dosage that may help increase treatment adherence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Abacavir 600mg + lamivudine 300mg in on table QD + efavirenz 600mg QD |
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| B | Experimental | Abacavir 600mg + lamivudine 300mg in ine tablet QD * lopinavir/ritonavir 400/100 mg BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kivexa | Drug | abacavir 600mg + lamivudine 300mg in one tablet QD |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the virological response over the 48 weeks of the study. | At 12, 24, 36 and 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the immunological efficacy (changes in CD4 and CD8 counts) of the combination studied over the follow-up period. | At 12, 24, 36 and 48 weeks. | |
| To evaluate the impact of treatment on the lipid profile. | At 12, 24, 36 and 48 weeks |
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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 |
|---|---|---|---|---|---|---|
| Institute of Infections and Tropical Diseases University of Brescia | Brescia | 25125 | Italy | |||
| Hospital Arquitecto Marcide |
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| To evaluate the tolerance and safety of the combination of Efavirenz + lamivudine + abacavir given once daily over the 48-week treatment period. | 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. |
| To analyse the mutations that appear in patients that present virological failure. | When there is a virological failure. |
| Ferrol |
| A Coruña |
| 15405 |
| Spain |
| Hospital Generall de Alicante | Alicante | Alacant | 03010 | Spain |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital de Granollers | Granollers | Barcelona | 08400 | Spain |
| Hospital Universitario de Canarias | Santa Cruz de Tenerife | Canary Islands | 38320 | Spain |
| Hospital Clínico Universitario de Santiago | Santiago de Compostela | Galicia | 15706 | Spain |
| Hospital Virgen de las Nieves | Granada | Granada | 18014 | Spain |
| Hopsital Gregorio Marañón | Madrid | Madrid | 28007 | Spain |
| Hospital 12 de Octubre | Madrid | Madrid | 28041 | Spain |
| Hopsital Costa del Sol | Marbella | Malaga | 29600 | Spain |
| Hospital Nuestra Sra del Rosell | Cartagena | Murcia | 30203 | Spain |
| Hospital General de Murcia | Murcia | Murcia | 30003 | Spain |
| Hospital Central de Asturias | Asturias | Oviedo | 33006 | Spain |
| Hospital Xeral de Vigo | Vigo | Pontevedra | 36204 | Spain |
| Hospital Virgen Macarena | Seville | Sevilla | 41009 | Spain |
| Hospital Virgen del Rocío | Seville | Sevilla | 41013 | Spain |
| Hospital de Tarragona | Tarragona | Tarragona | 43007 | Spain |
| Hospital Universitari Dr. Peset | Valencia | Valencia | 46017 | Spain |
| Hospital Miguel Servet | Zaragoza | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| 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 |
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| ID | Term |
|---|---|
| C492871 | abacavir, lamivudine drug combination |
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