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Clinical Trial: Randomized, Open-Label, Comparative Safety and Efficacy Study of Tipranavir Boosted with Low-Dose Ritonavir (TPV/RTV) Versus Genotypically-Defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-Experienced Patients (RESIST 2)
This study is no longer recruiting patients.
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Purpose
The objective of this trial is to determine the safety and efficacy of TPV/RTV versus an active control arm in highly treatment experienced HIV-1 infected patients.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections | Drug: Tipranavir (with low dose ritonavir) | Phase III |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title: Randomized, Open-Label, Comparative Safety and Efficacy Study of Tipranavir Boosted with Low Dose Ritonavir (TPV/RTV) Versus Genotipically-Defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-Experienced Patients (RESIST 2: Randomized Evaluation of Strategic Intervention in
Further Study Details:
Primary Outcomes: The primary endpoints of the study are the proportion of patients with a treatment response at 48 weeks and the time to treatment failure through 48 weeks.
Secondary Outcomes: The key secondary endpoint of the study to be assessed at an interim analysis, is the proportion of patients with a virologic response at 16 weeks. Additional secondary endpoints are listed in the protocol.
Expected Total Enrollment: 891
Secondary Outcomes: The key secondary endpoint of the study to be assessed at an interim analysis, is the proportion of patients with a virologic response at 16 weeks. Additional secondary endpoints are listed in the protocol.
Expected Total Enrollment: 891
Study start: February 2003; Study completion: May 2009
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
This study will be conducted in HIV+, multiple ARV drug experienced patients. All patients must have received treatment from each of the 3 ARV classes with at least two PI-based ARV regimens, have a viral load >1000 copies/mL at screening, and be on a PI based regimen at the time of study entry. To enter the study, at least one primary PI mutation at sites 30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M must be present, but no more than two mutations on codons 33, 82, 84 and 90 may be present in the patient''''s genotype report at screening.
Location Information
Study chairs or principal investigators
Ante Jelaska, Dr.
More Information
Study ID Numbers: 1182.48
Last Updated: September 2, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00144170
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 2, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00144170
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- A MDI and Inspirease Spacer (Cleveland Clinic)
- Metered Dose Inhaler (Cleveland Clinic)
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