Study on the Effect of Kaletra + Nevirapine as Maintenance Bitherapy Compared to a Triple Therapy Including Kaletra + Analogues in HIV Patients
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| ClinicalTrials.gov Identifier: NCT00335686 |
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Recruitment Status
:
Completed
First Posted
: June 12, 2006
Last Update Posted
: February 29, 2008
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Sponsor:
Germans Trias i Pujol Hospital
Collaborator:
Fundacio Lluita Contra la SIDA
Information provided by:
Germans Trias i Pujol Hospital
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h Drug: Nevirapine (Viramune): 1 comp (200mg)/12h | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 67 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Randomised, Prospective Multicentre Clinical Study on the Effect of the Combination of Lopinavir/Rtv + Nevirapine as Maintenance Bitherapy (Without Nucleoside Analogues) in Comparison With a Triple Therapy Including Lopinavir/Rtv + Nucleoside Analogues in HIV-Infected Patients |
| Study Start Date : | October 2003 |
| Actual Primary Completion Date : | March 2006 |
| Actual Study Completion Date : | March 2006 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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No Intervention: 1
Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
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Drug: Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
|
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No Intervention: 2
Nevirapine (Viramune): 1 comp (200mg)/12h
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Drug: Nevirapine (Viramune): 1 comp (200mg)/12h
Nevirapine (Viramune): 1 comp (200mg)/12h
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Primary Outcome Measures
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- The primary outcome measures are changes in the mDNA/nDNA ratio at each visit with regard to the baseline visit. [ Time Frame: At 24 and 48 weeks with regard to the baseline visit ]
Secondary Outcome Measures
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- 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 [ Time Frame: At 12, 24, 36 and 48 weeks. ]
- and CV<50 copies/mL over at last 6 months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At 12, 24, 36 and 48 weeks ]
- To evaluate the tolerance and safety of the combination of Lopinavir-rtv+Nevirapine . [ Time Frame: over 48 weeks of treatment ]
- To evaluate treatment adherence and patient quality of life (evaluated by means of the MOS_HIV questionnaire). [ Time Frame: At 12, 24, 36 and 48 weeks ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age >= 18 years.
- HIV-1 infected patients.
- Patients on HAART therapy with PIs or NNRTIs.
- Patients with an undetectable viral load (<50/80 copies/mL) over the last 6 months (at least 2 determinations separated by 2 months).
- Hepatic tests < 5 times the normal value.
- Subject able to follow the treatment period.
- Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study.
- Signature of the informed consent
Exclusion Criteria:
- Presence of opportunistic infections and/or recent tumours (< 6 months).
- Suspicion of resistance or documented resistance to any of the investigational drugs.
- Suspicion of possible bad adherence.
- Pregnancy or breastfeeding; refusal to follow reliable contraception over the treatment period.
- Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
- Patients participating in another clinical trial.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335686
Locations
| Spain | |
| Hospital C. Universitario de Santiago | |
| Santiago, A Coruña, Spain, 15706 | |
| Hospital General Universitario de Elche | |
| Elche, Alicante, Spain, 03203 | |
| Hospital Can Mises | |
| Ibiza, Baleares, Spain, 07800 | |
| Hospital Universitari Germans Trias i Pujol | |
| Badalona, Barcelona, Spain, 08916 | |
| Hospital de Granollers | |
| Granollers, Barcelona, Spain, 08400 | |
| Mutua de Terrassa | |
| Terrassa, Barcelona, Spain, 08221 | |
| Hospital General de Castellón | |
| Castello, Castellón, Spain, 12004 | |
| Hospital de Figueres | |
| Figueres, Girona, Spain, 17600 | |
| Hospital de Palamós | |
| Palamós, Girona, Spain, 17230 | |
| Hospital Virgen del Toro | |
| Mahón, Menorca, Spain, 07701 | |
| Hospital Nuestra Señora del Rosell | |
| Cartagena, Murcia, Spain, 30071 | |
| Hospital C. Universitario Virgen de la Victoria | |
| Malaga, Málaga, Spain, 29010 | |
| Hospital Costa del Sol | |
| Marbella, Málaga, Spain, 29600 | |
| Hospital Central de Asturias | |
| Asturias, Oviedo, Spain, 33006 | |
| Hospital Sant Joan de Reus | |
| Reus, Tarragona, Spain, 43201 | |
| Hospital General Universitario de Alicante | |
| Alicante, Spain, 03010 | |
| Hospital de Sant Pau | |
| Barcelona, Spain, 08025 | |
| Hospital de Mataró | |
| Barcelona, Spain, 08304 | |
| Hospital C. San Carlos | |
| Madrid, Spain, 28040 | |
| Hospital Marqués de Valdecilla | |
| Santander, Spain, 39008 | |
| Hospital Universitario Joan XXIII de Tarragona | |
| Tarragona, Spain, 43007 | |
| Hospital Clínico de Valencia | |
| Valencia, Spain, 46010 | |
| Hospital Arnau de Vilanova | |
| Valencia, Spain, 46015 | |
| Hospital Xeral Cies de Vigo | |
| Vigo, Spain, 36204 | |
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Fundacio Lluita Contra la SIDA
Investigators
| Principal Investigator: | Bonaventura Clotet, MD,PhD | Lluita contra la Sida Foundation-HIV Unit |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | LLuita Sida Foundation |
| ClinicalTrials.gov Identifier: | NCT00335686 History of Changes |
| Other Study ID Numbers: |
MULTINEKA |
| First Posted: | June 12, 2006 Key Record Dates |
| Last Update Posted: | February 29, 2008 |
| Last Verified: | June 2007 |
Keywords provided by Germans Trias i Pujol Hospital:
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Mitochondrial toxicity Lopinavir-rtv Nevirapine DNA mitochondrial/DNA nuclear |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lopinavir Nevirapine HIV Protease Inhibitors Protease Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |