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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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, limits its efficacy for the treatment of HIV-infected patients, due to the high incidence of gastrointestinal adverse events. Nevertheless, tipranavir plasma though concentrations were higher than the proposed minimum effective concentration for patients with previous experience with protease inhibitors (PI) in half of patients treated with tipranavir/ritonavir at 500/100 mg dose every 12 hours. Furthermore, when the number of mutations in the protease gene is limited, there are no differences in the reduction of the viral load between patients treated with tipranavir/ritonavir at 500/200 mg and 500/100 mg every 12 hours. At last, the efficacy of tipranavir treatment has been more closely related with the inhibition quotient (IQ) than with concentrations considered isolated.

Considering the previous arguments, it can be hypothesized that, basing in every subject IQ, it could be possible to identify those patients HIV-infected in treatment with tipranavir/ritonavir at 500/200 mg every 12 hours that could take advance of the reduction of ritonavir to 100 mg every 12 hours, without compromising the viral replication control. This strategy could improve the tolerability to the treatment, what could result in a better adherence and less proportion of treatment abandon due to this reason

• 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: Ritonavir; Tipranavir

Criteria

Inclusion Criteria:

1. Age +=18 years.

2. HIV-infected patients.

3. Stable antiretroviral treatment including tipranavir/ritonavir 500/200 every 12 hours for at least 4 weeks.

4. HIV viral load <50 copies/mL for at least 12 weeks.

5. Resistance test (Genotype or Virtual Phenotype) before starting tipranavir treatment.

6. Tipranavir IQ +=60.

7. Subject able to follow the treatment period.

8. 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.

9. Signature of the informed consent.

Exclusion Criteria:

1. AIDS-defining illness in the last 4 weeks.

2. Suspicion of unsuitable antiretroviral treatment compliance.

3. In women, pregnancy or breastfeeding.

4. Record or suspicion of incapability to cooperate as appropriate.