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| Sponsor: | The Huesped Foundation |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | The Huesped Foundation |
| ClinicalTrials.gov Identifier: | NCT01013987 |
Purpose
Phase 4, single arm, open label study designed to compare the safety and efficacy of antiviral activity and immunological effect of Maraviroc in combination with Raltegravir and Darunavir/Ritonavir for treatment of triple class failure in adult HIV-1 infected subjects.
The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: maraviroc, darunavir and raltegravir in patients who have multi-resistant viruses and limited treatment options. Patients will undergo treatment for 48 weeks; safety and virological efficacy will be preliminary evaluated at weeks 16 and 24.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-1 Adults Patients AIDS Triple Class Failure |
Drug: maraviroc Drug: Raltegravir Drug: Darunavir/ritonavir |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 4, Single Arm, Open Label, Pilot Study of Maraviroc (Celsentri) in Combination With Raltegravir and Darunavir/Ritonavir for the Treatment of Triple Class Failure in Adult HIV-1 Infected Patients. |
| Estimated Enrollment: | 60 |
This is a Phase 4, single arm, open-label, study designed to demonstrate the safety, tolerability, efficacy, antiviral and immunological activity of Maraviroc in combination with Raltegravir and Darunavir/Ritonavir in patients with limited to no treatment option in HIV-1 infected subjects ≥ 21 years old.
The trial population will comprise 60 HIV-infected subjects with history of triple class antiretroviral failure, naïve to CCR5-inhibitors, integrase-inhibitors and darunavir will be evaluated. Single arm, stratified according to plasma viral load at screening (> or < 100,000 copies/ml).
Those with evidence of R5 viruses and susceptibility to darunavir in the resistance testing analysis, plus history of failure to NRTIs, NNRTIs and at least one PI, plus a genotype analysis showing evidence of resistance to NRTIs (at least 2 TAMS and/or Q151M and or 69ss), resistance to PIs (at least 2 major mutations), will start a regimen of maraviroc, raltegravir and ritonavir boosted darunavir.
This trial will consist of a screening period of up to 6 weeks, a 48-week treatment period, with interim analysis at 16 and 24 weeks. Followed by a 4-week post-treatment follow-up (FU) period.
Virologic response, CD4 count change, clinical outcomes and safety will be followed throughout the study.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
If female, subject must be either postmenopausal for at least one year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or she must:
Exclusion Criteria:
Screening laboratory analysis show any of the following abnormal laboratory results:
Contacts and Locations| Contact: Alejandro Krolewiecki, MD | 54-11-4981-7777 ext 114 | alekrol@huesped.org.ar |
| Argentina | |
| Fundación Huésped | |
| Ciudad de Buenos Aires, Argentina, C1202ABB | |
More Information
| Responsible Party: | Fundación Huésped ( Pedro Cahn ) |
| Study ID Numbers: | TERCETO |
| Study First Received: | November 13, 2009 |
| Last Updated: | November 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT01013987 History of Changes |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
|
HIV-1 triple class failure Maraviroc |
Raltegravir Darunavir/ritonavir Maraviroc with raltegravir and darunavir/ritonavir |
|
Anti-Infective Agents HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action Ritonavir |
Therapeutic Uses Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Darunavir Protease Inhibitors |