Status:
COMPLETED
Clinical Trial to Assess the Security of the Dose Reduction of Ritonavir in HIV-Infected Patients in Treatment With Tipranavir/Ritonavir 500/200 mg Every 12 Hours
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+ years
Phase:
PHASE4
Brief Summary
Tipranavir is a drug with a high antiretroviral activity, also in presence of major mutations in the protease gene. However, its necessity of being co-administered with 400 mg of ritonavir daily, limi...
Detailed Description
Tipranavir efficacy as a rescue treatment in HIV-infected patients was assessed in the RESIST studies, which included patients with a wide antiretroviral experience who were found in viral failure des...
Eligibility Criteria
Inclusion
- Age +=18 years.
- HIV-infected patients.
- Stable antiretroviral treatment including tipranavir/ritonavir 500/200 every 12 hours for at least 4 weeks.
- HIV viral load \<50 copies/mL for at least 12 weeks.
- Resistance test (Genotype or Virtual Phenotype) before starting tipranavir treatment.
- Tipranavir IQ +=60.
- Subject able to follow the treatment period.
- In women, negative pregnancy test or not in fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or undertaking to use a barrier contraceptive method during the study.
- Signature of the informed consent.
Exclusion
- AIDS-defining illness in the last 4 weeks.
- Suspicion of unsuitable antiretroviral treatment compliance.
- In women, pregnancy or breastfeeding.
- Record or suspicion of incapability to cooperate as appropriate.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00607958
Start Date
December 1 2007
End Date
May 1 2009
Last Update
December 5 2019
Active Locations (1)
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1
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916