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| Tracking Information | |||||||||||||||||||||
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| First Received Date ICMJE | September 20, 2006 | ||||||||||||||||||||
| Last Updated Date | October 10, 2008 | ||||||||||||||||||||
| Start Date ICMJE | June 2006 | ||||||||||||||||||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Virological response: Viral Load [ Time Frame: weeks 24 and 48 ] [ Designated as safety issue: No ] | ||||||||||||||||||||
| Original Primary Outcome Measures ICMJE |
Virological response: Viral Load | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00379405 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | Saquinavir/Ritonavir in Single Therapy as Maintenance Treatment | ||||||||||||||||||||
| Official Title ICMJE | Open-Label, Comparative and Randomised Pilot Study to Evaluate the Efficacy and Safety of Saquinavir/Ritonavir in Single Therapy vs Standard HAART Therapy as Maintenance Therapy. | ||||||||||||||||||||
| Brief Summary | Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance therapy, compared to standard HAART therapies. |
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| 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 improvement in therapeutic compliance. Similarly, the administration of new treatment regimens with a reduced number of tablets a day and without NTRI may be clinically useful in improving compliance with HAART and limiting NTRI-associated toxicity. These would comprise combinations of a PI, boosted with ritonavir, plus a non-Nucleoside and single therapy with PIs boosted with ritonavir. In this regard, the results obtained with lopinavir/ritonavir and with atazanavir/ritonavir are very promising and open up a possible channel of research with other PIs boosted with low doses of ritonavir. There are other PIs whose antiretroviral efficacy has also been demonstrated, such as saquinavir, but whose economic cost is much lower. Furthermore, saquinavir has a low toxicity profile, and the availability of saquinavir 500 mg facilitates comfortable administration, since it makes it possible to reduce the number of daily tablets to more than half. Moreover, it is important to take into account that the incidence of mutations that confer resistance to saquinavir on patients that fail on combinations including this PI is very low, which makes it possible to reuse the drug in future treatment regimens or salvage patients with other PI All these characteristics (high intrinsic potency, low number of tablets, low toxicity, low potential of selection of resistant viral strains in combination with ritonavir, and low economic cost) make single therapy with the new formulation of saquinavir, boosted with low doses of ritonavir, a possible therapeutic option as maintenance strategy in HIV-infected patients with maintained suppression of the viral load. |
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| Study Phase | Phase IV | ||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||||||||||||||
| Condition ICMJE | HIV Infections | ||||||||||||||||||||
| Intervention ICMJE | Drug: Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours | ||||||||||||||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||
| Enrollment ICMJE | 30 | ||||||||||||||||||||
| Completion Date | July 2008 | ||||||||||||||||||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||
| Ages | 18 Years to 65 Years | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||
| Location Countries ICMJE | Spain | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT ID ICMJE | NCT00379405 | ||||||||||||||||||||
| Responsible Party | Lluita Sida Foundation, Lluita Sida Foundation | ||||||||||||||||||||
| Study ID Numbers ICMJE | SQV/RTV-MONOTERAPIA, 2006-001136-47 | ||||||||||||||||||||
| Study Sponsor ICMJE | Germans Trias i Pujol Hospital | ||||||||||||||||||||
| Collaborators ICMJE | FUNDACIÓ LLUITA CONTRA LA SIDA | ||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Germans Trias i Pujol Hospital | ||||||||||||||||||||
| Verification Date | October 2008 | ||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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