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

Germans Trias i Pujol Hospital

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: Nevirapine (Viramune): 1 comp (200mg)/12h; Drug: Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h

Study type: Interventional

Funder types: Other

Identifiers

NCT00335686

MULTINEKA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

1

No Intervention group

Description:

Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h

Treatment:

Drug: Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h

2

No Intervention group

Description:

Nevirapine (Viramune): 1 comp (200mg)/12h

Treatment:

Drug: Nevirapine (Viramune): 1 comp (200mg)/12h