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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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The study aims to evaluate the changes in mitochondrial DNA (mDNA) by means of the mDNA/nuclearDNA (nDNA) ratio as a marker of mitochondrial toxicity following the interruption of nucleoside analogues.
At the moment it is known that mitochondrial toxicity is the main pathogenic mechanism of toxicity associated with nucleoside analogues, including lipoatrophy, which at facial level is a stigmatising factor for patients with HIV infection.
The primary outcome measure of the design of an "NTRI-sparing" bitherapy is to retard the onset of mitochondrial toxicity or reverse it, mainly with regard to the loss of subcutaneous fat or lipoatrophy.
Lopinavir/ritonavir and nevirapine are two antiretrovirals with different mutation patterns and with high antiviral potency. Their combination therefore guarantees antiviral success. The NEKA study endorses efficacy immunologically and virologically (Negredo E. et al, NRTI-sparing regimen. XIV International AIDS Conference. Barcelona 2002. LB PeB9021).
Similarly, the protective effect of nevirapine on lipid metabolism would counteract the negative impact attributed to lopinavir/ritonavir, reducing cardiovascular risk in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h |
|
| 2 | No Intervention | Nevirapine (Viramune): 1 comp (200mg)/12h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h | Drug | Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measures are changes in the mDNA/nDNA ratio at each visit with regard to the baseline visit. | At 24 and 48 weeks with regard to the baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| Study of the efficacy of the therapy with Lopinavir/rtv (3 tablets every 12 h) + Nevirapine (1 tablet every 12 h) in the maintenance of viral suppression and immune recovery in patients on HAART therapy for more than 9 months | At 12, 24, 36 and 48 weeks. | |
| and CV<50 copies/mL over at last 6 months |
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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 |
|---|---|---|---|---|---|---|
| Hospital C. Universitario de Santiago | Santiago | A Coruña | 15706 | Spain | ||
| Hospital General Universitario de Alicante |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19663689 | Derived | Negredo E, Miro O, Rodriguez-Santiago B, Garrabou G, Estany C, Masabeu A, Force L, Barrufet P, Cucurull J, Domingo P, Alonso-Villaverde C, Bonjoch A, Moren C, Perez-Alvarez N, Clotet B; MULTINEKA Study Group. Improvement of mitochondrial toxicity in patients receiving a nucleoside reverse-transcriptase inhibitor-sparing strategy: results from the Multicenter Study with Nevirapine and Kaletra (MULTINEKA). Clin Infect Dis. 2009 Sep 15;49(6):892-900. doi: 10.1086/605440. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 19, 2018 | |
| Reset | Oct 22, 2018 | |
| Release | Jun 3, 2019 |
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| Nevirapine (Viramune): 1 comp (200mg)/12h | Drug | Nevirapine (Viramune): 1 comp (200mg)/12h |
|
| At 12, 24, 36 and 48 weeks |
| To determine whether the combination with Lopinavir/rtv +Nevirapine is efficacious in avoiding progression to lipoatrophy/lipodystrophy or else the reversal thereof | At 24 and 48 weeks |
| To study whether the combination with Lopinavir/rtv +Nevirapine makes it possible to control dyslipidemia associated with the use of Lopinavir/rtv on proving the "lipid-lowering" action of NVP | At 12, 24, 36 and 48 weeks. |
| To check whether the simplified combination with the standard dose of Lopinavir/rtv with NVP is sufficient to maintain suppression of viral replication. Pharmacokinetic studies (PK) would be performed to estimate this point | At 12, 24, 36 and 48 weeks |
| To evaluate the tolerance and safety of the combination of Lopinavir-rtv+Nevirapine . | over 48 weeks of treatment |
| To evaluate treatment adherence and patient quality of life (evaluated by means of the MOS_HIV questionnaire). | At 12, 24, 36 and 48 weeks |
| Alicante |
| Alicante |
| 03010 |
| Spain |
| Hospital General Universitario de Elche | Elche | Alicante | 03203 | Spain |
| Hospital Can Mises | Ibiza Town | Balearic Islands | 07800 | Spain |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital de Sant Pau | Barcelona | Barcelona | 08025 | Spain |
| Hospital de Mataró | Barcelona | Barcelona | 08304 | Spain |
| Hospital de Granollers | Granollers | Barcelona | 08400 | Spain |
| Mutua de Terrassa | Terrassa | Barcelona | 08221 | Spain |
| Hospital Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital General de Castellón | Castelló | Castellón | 12004 | Spain |
| Hospital de Figueres | Figueres | Girona | 17600 | Spain |
| Hospital de Palamós | Palamós | Girona | 17230 | Spain |
| Hospital C. San Carlos | Madrid | Madrid | 28040 | Spain |
| Hospital Virgen del Toro | Mahón | Menorca | 07701 | Spain |
| Hospital Nuestra Señora del Rosell | Cartagena | Murcia | 30071 | Spain |
| Hospital Costa del Sol | Marbella | Málaga | 29600 | Spain |
| Hospital C. Universitario Virgen de la Victoria | Málaga | Málaga | 29010 | Spain |
| Hospital Central de Asturias | Asturias | Oviedo | 33006 | Spain |
| Hospital Sant Joan de Reus | Reus | Tarragona | 43201 | Spain |
| Hospital Universitario Joan XXIII de Tarragona | Tarragona | Tarragona | 43007 | Spain |
| Hospital Clínico de Valencia | Valencia | Valencia | 46010 | Spain |
| Hospital Arnau de Vilanova | Valencia | Valencia | 46015 | Spain |
| Hospital Xeral Cies de Vigo | Vigo | Vigo | 36204 | Spain |
| Reset | Jul 26, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 19, 2018 | Oct 22, 2018 | |||
| Jun 3, 2019 | Jul 26, 2019 |
| 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 |
|---|---|
| C558899 | lopinavir-ritonavir drug combination |
| D019829 | Nevirapine |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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