Saquinavir/Ritonavir in Single Therapy as Maintenance Treatment

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance therapy, compared to standard HAART therapies.

• 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; Saquinavir

Criteria

Inclusion Criteria:

• Patients infected by HIV-1 (at least one documented positive Western-Blot).

• Age > 18 years.

• Patients on antiretroviral treatment (standard HAART therapy) for at least six months.

• HIV-1 plasma viral load <50 copies/mL (documented in at least two determinations performed over the six months prior to the inclusion visit).

• Patients without evidence of previous virological failure to IP

• Absence of opportunistic infections and/or tumours in the three months prior to inclusion.

• Subject able to follow the treatment period, without any suspicion of poor adherence during previous antiretroviral treatments.

• Signature of the informed consent.

Exclusion Criteria:

• Suspicion of unsuitable antiretroviral treatment compliance.

• Documented existence of any of the primary mutations in the protease gene or 3 or more of the following: L10F/I/R/V, K20M/R, M36I/V, I54L/T/V, L63P, A71T/V , V82A/F/T/S, I84A/V OR L90M.

• Known allergic hypersensitivity to any of the investigational drugs or any similar drug.

• Hepatic tests (AST, ALT, GGT) > or equal to 5 times the upper limit of normality during the three months prior to the screening visit

• Presence of renal impairment (creatinine > or equal to 1.5 times the upper limit of normality).

• Pregnancy or breastfeeding. Refusal to use reliable contraceptive methods during the study period.

• Participation in another clinical trial wich entail the antiretroviral treatment modification.