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

Phase 4

Completed

• Conditions: HIV Infections

• Registration Number: NCT00335686
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Study First Submitted: 2006-06-08
• Study First Submitted QC: 2006-06-09
• Study First Posted: 2006-06-12
• Status Verified: 2007-06
• Last Update Submitted: 2008-02-19
• Last Update Posted: 2008-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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.
To evaluate the tolerance and safety of the combination of Lopinavir-rtv+Nevirapine .	over 48 weeks of treatment
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 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
and CV<50 copies/mL over at last 6 months	At 12, 24, 36 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 evaluate treatment adherence and patient quality of life (evaluated by means of the MOS_HIV questionnaire).	At 12, 24, 36 and 48 weeks

Trial Locations

Locations (24)

Hospital C. Universitario de Santiago; 🇪🇸 Santiago, A Coruña, Spain

Hospital General Universitario de Elche; 🇪🇸 Elche, Alicante, Spain

Hospital Can Mises; 🇪🇸 Ibiza, Baleares, Spain

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital de Granollers; 🇪🇸 Granollers, Barcelona, Spain

Mutua de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital General de Castellón; 🇪🇸 Castello, Castellón, Spain

Hospital de Figueres; 🇪🇸 Figueres, Girona, Spain

Hospital de Palamós; 🇪🇸 Palamós, Girona, Spain

Hospital Virgen del Toro; 🇪🇸 Mahón, Menorca, Spain

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