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Study on the Effect of Kaletra + Nevirapine as Maintenance Bitherapy Compared to a Triple Therapy Including Kaletra + Analogues in HIV Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00335686
Recruitment Status : Completed
First Posted : June 12, 2006
Last Update Posted : February 29, 2008
Fundacio Lluita Contra la SIDA
Information provided by:
Germans Trias i Pujol Hospital

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

Detailed Description:

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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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

Arm Intervention/treatment
No Intervention: 1
Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
Drug: Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h
Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h

No Intervention: 2
Nevirapine (Viramune): 1 comp (200mg)/12h
Drug: Nevirapine (Viramune): 1 comp (200mg)/12h
Nevirapine (Viramune): 1 comp (200mg)/12h

Primary Outcome Measures :
  1. 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 :
  1. 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. ]
  2. and CV<50 copies/mL over at last 6 months [ Time Frame: At 12, 24, 36 and 48 weeks ]
  3. 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 ]
  4. 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. ]
  5. 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 ]
  6. To evaluate the tolerance and safety of the combination of Lopinavir-rtv+Nevirapine . [ Time Frame: over 48 weeks of treatment ]
  7. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age >= 18 years.
  2. HIV-1 infected patients.
  3. Patients on HAART therapy with PIs or NNRTIs.
  4. Patients with an undetectable viral load (<50/80 copies/mL) over the last 6 months (at least 2 determinations separated by 2 months).
  5. Hepatic tests < 5 times the normal value.
  6. Subject able to follow the treatment period.
  7. 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.
  8. Signature of the informed consent

Exclusion Criteria:

  1. Presence of opportunistic infections and/or recent tumours (< 6 months).
  2. Suspicion of resistance or documented resistance to any of the investigational drugs.
  3. Suspicion of possible bad adherence.
  4. Pregnancy or breastfeeding; refusal to follow reliable contraception over the treatment period.
  5. Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
  6. 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 identifier (NCT number): NCT00335686

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Sponsors and Collaborators
Germans Trias i Pujol Hospital
Fundacio Lluita Contra la SIDA
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Principal Investigator: Bonaventura Clotet, MD,PhD Lluita contra la Sida Foundation-HIV Unit
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: LLuita Sida Foundation Identifier: NCT00335686    
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:
Mitochondrial toxicity
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
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