Status:
COMPLETED
Study on the Effect of Kaletra + Nevirapine as Maintenance Bitherapy Compared to a Triple Therapy Including Kaletra + Analogues in HIV Patients
Lead Sponsor:
Germans Trias i Pujol Hospital
Collaborating Sponsors:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Conditions:
HIV Infections
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00335686
Start Date
October 1 2003
End Date
March 1 2006
Last Update
February 29 2008
Active Locations (24)
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1
Hospital C. Universitario de Santiago
Santiago, A Coruña, Spain, 15706
2
Hospital General Universitario de Alicante
Alicante, Alicante, Spain, 03010
3
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
4
Hospital Can Mises
Ibiza Town, Balearic Islands, Spain, 07800