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

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Germans Trias i Pujol Hospital
• Collaborators: Fundacio Lluita Contra la SIDA; Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Treatments: Lopinavir; Nevirapine

Criteria

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.