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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protease Inhibitor Group | Subjects who required a protease inhibitor in their new ART regimen |
| |
| Non-protease Inhibitor | Subjects who did not take a protease inhibitor in their regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| raltegravir | Drug | New combination ART incorporating raltegravir with other ARVs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Viral Load < 400 Copies /mL at Week 12. | The HIV RNA (viral load) was measured using standard of care testing via local laboratories. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12 | The HIV RNA (viral load) was measured using standard of care testing via local laboratories. | 12 weeks |
| CD4 Cell Changes Among Participants in PI vs Non-PI Group |
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Inclusion Criteria:
Patients previously enrolled in the MK 0518 EAP are eligible
Patients not enrolled in the MK 0518 EAP (or other Raltegravir protocols) but who meet the specific EAP protocol entry criteria are eligible:
Patient received raltegravir for at least 8 weeks
Baseline and week 8 or later HIV viral load done and available for review
Resistance test (either genotypic or phenotypic test) available prior to receipt of raltegravir
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Skiest, MD | Community Research Initiative | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Light Source Medical | Los Angeles | California | 900036 | United States | ||
| AIDS Healthcare Foundation |
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| ID | Title | Description |
|---|---|---|
| FG000 | Protease Inhibitor Group | Subjects who required a protease inhibitor in their new ART regimen |
| FG001 | Non-protease Inhibitor | Subjects who did not take a protease inhibitor in their regimen |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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CD4 cell counts were measured using standard of care testing via local laboratories.
| baseline to 24 Weeks |
| Baseline Genotypic Sensitivity Score (GSS). The Minimal Value Was 0 and the Maximum Values Was 5.4. (0 = Minimal to no Activity in Regimen and 5.4 = High to Maximal Activity in Regimen) | The baseline GSS is calculated by the sum of resistance scores for each drug in the regimen. For each drug in the regimen a resistance score of 0, 0.5 or 1 was assigned for high, low or no levels of resistance, respectfully. The resistance assignment was based on either the Stanford database interpretation or presence of primary IAS mutation levels of resistance. Inclusion of maraviroc or new use of enfuvirtide in the regimen was scored a 1.0. The sum of the scores of the active drugs, not including raltegravir, constituted the baseline GSS. | Baseline |
| Percentage of Participants Using Etravirine in Background Regimen | These results report the percent of participants using Etravirine in the background regimen. | Background regimen (no specific time frame) |
| Los Angeles |
| California |
| 90028 |
| United States |
| Synergy Hematology and Oncology | Los Angeles | California | 90036 | United States |
| Quest Clinical Research | San Francisco | California | 94115 | United States |
| Connecticut Health Care Group | Glastonbury | Connecticut | 06033 | United States |
| Dupont Circle Physicians Group | Washington D.C. | District of Columbia | 20009 | United States |
| Capital Medical Associates PC | Washington D.C. | District of Columbia | 20036 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Ruth M. Rothstein CORE Center | Chicago | Illinois | 60612 | United States |
| Community Research Initiative | Boston | Massachusetts | 02215 | United States |
| Community Research Initiative - West | Springfield | Massachusetts | 01107 | United States |
| Infectious Diseases and HIV Medicine Immunodeficiency Clinic | Buffalo | New York | 14215 | United States |
| Bellman, MD | New York | New York | 10003 | United States |
| Mounzer, MD | Philadelphia | Pennsylvania | 19107 | United States |
| Dr. Nicholaos C. Bellos & Associates | Dallas | Texas | 75204 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Protease Inhibitor Group | Subjects who required a protease inhibitor in their new ART regimen |
| BG001 | Non-protease Inhibitor | Subjects who did not take a protease inhibitor in their regimen |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12 | The HIV RNA (viral load) was measured using standard of care testing via local laboratories. | Posted | Jul 2010 | Number | Percentage of participants | 12 weeks |
|
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| |||||||||||||||||||||||||||||
| Secondary | CD4 Cell Changes Among Participants in PI vs Non-PI Group | CD4 cell counts were measured using standard of care testing via local laboratories. | Posted | Jul 2010 | Mean | Full Range | cells/mm3 | baseline to 24 Weeks |
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| |||||||||||||||||||||||||||||
| Secondary | Baseline Genotypic Sensitivity Score (GSS). The Minimal Value Was 0 and the Maximum Values Was 5.4. (0 = Minimal to no Activity in Regimen and 5.4 = High to Maximal Activity in Regimen) | The baseline GSS is calculated by the sum of resistance scores for each drug in the regimen. For each drug in the regimen a resistance score of 0, 0.5 or 1 was assigned for high, low or no levels of resistance, respectfully. The resistance assignment was based on either the Stanford database interpretation or presence of primary IAS mutation levels of resistance. Inclusion of maraviroc or new use of enfuvirtide in the regimen was scored a 1.0. The sum of the scores of the active drugs, not including raltegravir, constituted the baseline GSS. | Posted | Jul 2010 | Mean | Full Range | score | Baseline |
|
| |||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Viral Load < 400 Copies /mL at Week 12. | The HIV RNA (viral load) was measured using standard of care testing via local laboratories. | Posted | Jul 2010 | Number | Percentage of Participants | 12 Weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Using Etravirine in Background Regimen | These results report the percent of participants using Etravirine in the background regimen. | Posted | Jul 2010 | Number | Percentage of Participants | Background regimen (no specific time frame) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Protease Inhibitor Group | Subjects who required a protease inhibitor in their new ART regimen | 0 | 0 | 0 | 0 | ||
| EG001 | Non-protease Inhibitor | Subjects who did not take a protease inhibitor in their regimen | 0 | 0 | 0 | 0 |
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Site Investigators (PIs) agree not to individually publish the results of the study. They may participate in a joint publication of the study results with the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Manager | Community Research Initiative | 617 502 1700 | pmacht@crine.org |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
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| Male |
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