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Sponsored by: |
Community Research Initiative of New England |
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Information provided by: | Community Research Initiative of New England |
ClinicalTrials.gov Identifier: | NCT00751530 |
This is a retrospective chart review of participants in raltegravir expanded access program and will compare virologic response in regimens not containing a protease inhibitor in the antiretroviral background regimen to regimens containing a protease inhibitor in the background regimen.
Condition | Intervention |
---|---|
HIV Infections |
Drug: 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 | Assigned Interventions |
---|---|
1 | Drug: raltegravir |
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 |
Principal Investigator: | Daniel Skiest, MD | Community Research Initiative |
Responsible Party: | CRI ( Daniel J. Skiest, M.D., Principal Investigator ) |
Study ID Numbers: | 07-11 |
Study First Received: | September 11, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00751530 History of Changes |
Health Authority: | United States: Institutional Review Board |
HIV AIDS raltegravir |
BRAVO protease inhibitor treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes Protease Inhibitors |
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection |
Pharmacologic Actions Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |