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The purpose of this study is to evaluate the proportion of patients with viral load of HIV-1 < 50 copies after 48 weeks of follow-up after randomization to change or not to nevirapine.
RTNI (reverse transcriptase nucleoside inhibitors) are a regular part of most antiretroviral combinations. The presence of a smaller or greater degree of cross resistance among all RTNI is increasingly better described and acknowledged, whereby the number of salvage regimens that may be built following the appearance of this resistance to these drugs is by no means unlimited.
This proactive treatment change in patients on RTNI-based regimens while the viral load is still suppressed would avoid the selective replication period under antiviral pressure following the failure of the regimen in which resistance-associated mutations accumulate. This therapeutic approach has demonstrated its effectiveness in clinical practice, albeit not in this scenario.
If we wait until the viral load is detectable there is sufficient evidence that resistance to RTNI will appear and that this resistance will compromise future salvage options.
To intensify with this proactive approach these combinations based on N/NNRTI (nucleotide analog), the NNRTI are an optimal alternative.There is vast experience with NVP in simplification/maintenance trials. In direct comparative simplification studies in patients with virological response, the response rates with NVP or EFV have shown no differences. With a relative risk (RR) of virological failure of 0.54 with regard to the continuation of PI (protease inhibitors), NVP is one of the best simplification treatment options in HIV-1-infected patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Follow with same ARV treatment | |
| 2 | Experimental | Switch one of ARV drugs to Nevirapine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nevirapine | Drug | Switch one of ARV drugs to Nevirapine |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with plasma viral load below 50 copies/mL . | after 48 weeks of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the appearance of viral load >50 copies/mL in both branches (two consecutive determinations with 4-week separation between both). | During the 48 weeks of follow-up. | |
| Evolution of the CD4 lymphocyte count at 48 weeks. | during 48 weeks of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josep Mª Llibre, MD,PhD | Hospital Sant Jaume de Calella | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital.Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Centre Penitenciari Brians |
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| Pattern of mutations associated with resistance in patients presenting virological failure. | When there is a virological failure |
| Incidence of adverse clinical effects and laboratory alterations, giving rise or not to the withdrawal of the investigational treatment. | during the 48 weeks of follow-up |
| Incidence of AIDS-defining events (CDC C events, 1993). | during the 48 weeks of follow-up |
| Mortality by any cause. | during the 48 weeks of follow-up |
| Barcelona |
| Barcelona |
| 08009 |
| Spain |
| Hopsital de Sant Pau | Barcelona | Barcelona | 08025 | Spain |
| Hospital Vall d'Hebron | Barcelona | Barcelona | 08035 | Spain |
| Hospital Clínic i Provincial de Barcelona | Barcelona | Barcelona | 08036 | Spain |
| Hospital Sant Jaume de Calella | Barcelona | Barcelona | 08370 | Spain |
| Centre Penitenciari Homes | Barcelona | Barcelona | Spain |
| Hospital General de Granollers | Granollers | Barcelona | 08400 | Spain |
| Centre Penitenciari Quatre Camins | Granollers | Barcelona | 08430 | Spain |
| Hospital de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Mutua de Terrassa | Terrassa | Barcelona | 08221 | Spain |
| Hospital La Candelaria | Santa Cruz de Tenerife | Canary Islands | 38010 | Spain |
| Hospital Clínico San Carlos de Madrid | Madrid | Madrid | 28040 | Spain |
| Hospital Universitari Sant Joan de Reus | Reus | Tarragona | 43201 | Spain |
| Hospital La Fe de Valencia | Valencia | Valencia | 46009 | Spain |
| Hospital Miguel Servet | Zaragoza | Zaragoza | 50009 | Spain |
| Hospital de Tortosa | Tortosa | 43500 | 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 |
|---|---|
| D019829 | Nevirapine |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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