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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this study is to determine whether treatment with Raltegravir further decreases HIV viral replication in HAART-suppressed, HIV-infected patients, potentially improving immune response to antiretroviral therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raltegravir | Active Comparator | For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines. |
|
| Placebo | Placebo Comparator | For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir | Drug | For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily, in addition to continuing to take their current anti-HIV medicines. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Each Group (Study Drug vs. Placebo) With Undetectable Plasma HIV-1 RNA, as Measured by an Ultra-sensitive Assay With a Limit of Detection of 1 Copy/mL at Week 12. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentage of Activated CD8+ T Cells (CD8+ T Cells That Co-express CD38 and HLA-DR) From Baseline to Week 24 | Baseline and Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Deeks, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital, Clinical Research Center | San Francisco | California | 94110 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21402547 | Result | Hatano H, Hayes TL, Dahl V, Sinclair E, Lee TH, Hoh R, Lampiris H, Hunt PW, Palmer S, McCune JM, Martin JN, Busch MP, Shacklett BL, Deeks SG. A randomized, controlled trial of raltegravir intensification in antiretroviral-treated, HIV-infected patients with a suboptimal CD4+ T cell response. J Infect Dis. 2011 Apr 1;203(7):960-8. doi: 10.1093/infdis/jiq138. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Raltegravir | For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines. |
| FG001 | Placebo | For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Raltegravir | For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines. |
| BG001 | Placebo |
| 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 |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants in Each Group (Study Drug vs. Placebo) With Undetectable Plasma HIV-1 RNA, as Measured by an Ultra-sensitive Assay With a Limit of Detection of 1 Copy/mL at Week 12. | Posted | Number | participants | Week 12 |
|
24 weeks
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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 | Raltegravir | For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Deeks, MD | University of California, San Francisco | 415-476-4082 | 404 | Steven.Deeks@ucsf.edu |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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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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| Placebo | Drug | For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines. |
|
| San Francisco Veterans Affairs Medical Center |
| San Francisco |
| California |
| 94121 |
| United States |
For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Percentage of Activated CD8+ T Cells (CD8+ T Cells That Co-express CD38 and HLA-DR) From Baseline to Week 24 | Posted | Mean | Standard Deviation | Percentage of Activated CD8+ T cells | Baseline and Week 24 |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Placebo | For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines. | 0 | 15 | 0 | 15 | 0 | 15 |
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| 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 |