Status:
COMPLETED
Saquinavir/Ritonavir in Single Therapy as Maintenance Treatment
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
18-65 years
Phase:
PHASE4
Brief Summary
Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance therapy, compared to standard HAART therapies.
Detailed Description
Different therapeutic strategies have been investigated to improve adherence to treatment and reduce toxicity. Both the reduction in the number of doses and the number of daily tablets have led to an ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00379405
Start Date
June 1 2006
End Date
July 1 2008
Last Update
December 4 2019
Active Locations (2)
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1
Germans Trias i Pujol University Hospital
Badalona, Barcelona, Spain, 08916
2
Hospital del Sant Pau.
Barcelona, Spain, 08025