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Sponsored by: |
Community Research Initiative of New England |
Information provided by: | Community Research Initiative of New England |
ClinicalTrials.gov Identifier: | NCT00751530 |
This is a retrospective chart review of participants in expanded access program that will compare virologic response in regimens not containing a protease inhibitor in the antiretroviral background regimen with regimens containing a protease inhibitor in the background regimen.
Condition |
HIV |
MedlinePlus related topics: | AIDS |
ChemIDplus related topics: | Raltegravir |
Study Type: | Observational |
Study Design: | Cohort, Retrospective |
Official Title: | Outcomes of Early Raltegravir Experience: Comparison of Virologic Response in Regimens Not Containing a Protease Inhibitor in the Antiretroviral Background Regimen Versus a Protease Inhibitor in the Background Regimen |
Estimated Enrollment: | 400 |
Groups/Cohorts |
1 |
2 |
EAP charts from patients at the study sites who meet the inclusion criteria will be reviewed and data abstracted. A comparison of the response to treatment by viral load measurement with raltegravir will be compared in patients whose regimens contained a protease inhibitor (PI) with those that did not contain a PI. Other endpoints will also be assessed including percent of patients with viral loads less than 400 copies/ml, less than 50 copies/ ml, CD4 cell changes, consequences of failure of raltegravir and use of predictive parameters such as GSS and PSS.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
The study population consists of individuals who were previously enrolled in raltegravir expanded access program(EAP) and completed at least 8 weeks of treatment with raltegravir, whose chart from EAP program is available for review, and whose resistance testing prior to initiation of raltegravir is available.
Inclusion Criteria:
Patients not enrolled in the MK 0518 EAP (or other Raltegravir protocols) but who meet the specific EAP protocol entry criteria are eligible:
Exclusion Criteria:
Contact: Anne Habel, BS | 617-502-1712 | ahabel@crine.org |
United States, California | |||||
Quest Clinical Research | Recruiting | ||||
San Francisco, California, United States, 94115 | |||||
Contact: Zach zach@questclinical.com | |||||
Principal Investigator: Jay Lalezari, MD | |||||
Synergy Hematology and Oncology | Recruiting | ||||
Los Angeles, California, United States, 90036 | |||||
Contact: Christine Marion 310-866-0490 christine@kenmarresearch.com | |||||
Principal Investigator: Michael Gottlieb, MD | |||||
AIDS Healthcare Foundation | Recruiting | ||||
Los Angeles, California, United States, 90028 | |||||
Contact: Zenaida Vasquez 818-380-2626 zenaida.vasquez@aidshealth.org | |||||
Principal Investigator: Homayoon Khanlou, MD | |||||
Light Source Medical | Recruiting | ||||
Los Angeles, California, United States, 900036 | |||||
Contact: Helen Abad, MA 323-954-1072 ext 224 habad@lightsourcemedical.com | |||||
Principal Investigator: Peter J Ruane, MD | |||||
United States, Connecticut | |||||
Connecticut Health Care Group | Recruiting | ||||
Glastonbury, Connecticut, United States, 06033 | |||||
Contact: Delia Hernandez, RN 860-657-0764 dhernandez@ctcg.com | |||||
Principal Investigator: Kenneth Abriola, MD | |||||
United States, District of Columbia | |||||
Dupont Circle Physicians Group | Recruiting | ||||
Washington, District of Columbia, United States, 20009 | |||||
Contact: Linda G Kirkman 202-745-0201 ext 17 research@dupontdocs.com | |||||
Principal Investigator: Douglas Ward, MD | |||||
United States, Florida | |||||
Orlando Immunology Center | Recruiting | ||||
Orlando, Florida, United States, 32803 | |||||
Contact: Janiza Veloz 407-647-3960 jveloz@oicorlando.com | |||||
Principal Investigator: Edwin DeJesus, MD | |||||
United States, Illinois | |||||
Ruth M. Rothstein CORE Center | Recruiting | ||||
Chicago, Illinois, United States, 60612 | |||||
Contact: Sonia Vibhakar, PharmD 312-572-4654 svibhakar@corecenter.org | |||||
Principal Investigator: Dave Barker, MD | |||||
United States, Massachusetts | |||||
Community Research Initiative | Recruiting | ||||
Boston, Massachusetts, United States, 02215 | |||||
Contact: Jodi Jensen, RN 617-502-1716 jjensen@crine.org | |||||
Principal Investigator: Calvin Cohen, MD | |||||
Community Research Initiative - West | Recruiting | ||||
Springfield, Massachusetts, United States, 01107 | |||||
Contact: Frances Santiago, RN 413-734-2264 ext 206 fsantiago@crine.org | |||||
Principal Investigator: Daniel Skiest, MD | |||||
United States, New York | |||||
Bellman, MD | Recruiting | ||||
New York, New York, United States, 10003 | |||||
Contact: Shur Singh 212-677-2611 studycoordinator99@yahoo.com | |||||
Principal Investigator: Paul C Bellman, MD | |||||
United States, Pennsylvania | |||||
Mounzer, MD | Recruiting | ||||
Philadelphia, Pennsylvania, United States, 19107 | |||||
Contact: Karam Mounzer, MD 215-985-4448 | |||||
Principal Investigator: Karam Mounzer, MD |
Community Research Initiative of New England |
Principal Investigator: | Daniel Skiest, MD | Community Research Initiative |
Responsible Party: | CRI ( Daniel J. Skiest, M.D., Principal Investigator ) |
Study ID Numbers: | 07-11 |
First Received: | September 11, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00751530 |
Health Authority: | United States: Institutional Review Board |
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