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Futility criteria
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Effect on HIV-1 cell reservoirs of the concomitant administration of intensive chemotherapy and the pharmacological blockade of CCR5 coreceptors: a pilot, open, randomized, and controlled clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Control) | No Intervention | Patients receiving intensive chemotherapy with/without stable antiretroviral therapy. Patients not receiving antiretroviral therapy will start it. Patients randomized to this group will not receive clinical trial treatment (neither Maraviroc or Placebo) | |
| Group 2 (Treatment) | Experimental | Patients receiving intensive chemotherapy with/without stable antiretroviral therapy and Maraviroc. Patients not receiving antiretroviral therapy will start this theraphy together with Maraviroc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maraviroc | Drug | Patients randomized to experimental control will start Maraviroc treatment before, during and after chemotherapy until lymphocytes level recovery. Maraviroc Dose: 300 mg/12 hours For patients receiving an HIV-protease inhibitor (except tipranavir or Fosamprenavir), the dose will be reduced to 150 mg/12hours For patients receiving Efavirenz dose the dose will be 600 mg/12hours |
| Measure | Description | Time Frame |
|---|---|---|
| number of resting memory CD4+ T cells latently infected with replicative HIV-1, expressed as IUPM | Primary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels | Same as chemotherapy treatment (expected average of 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Proviral DNA (copies/million cells) | Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels | Same as chemotherapy treatment (expected average of 6 months) |
| Effector T cells producing HIV-1 specific gamma interferon (cells/mm3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Ramon Y Cajal | Madrid | Madrid | 28034 | Spain | ||
| Hospital Universitario La Paz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15319852 | Background | Wang C, Vlahov D, Galai N, Bareta J, Strathdee SA, Nelson KE, Sterling TR. Mortality in HIV-seropositive versus -seronegative persons in the era of highly active antiretroviral therapy: implications for when to initiate therapy. J Infect Dis. 2004 Sep 15;190(6):1046-54. doi: 10.1086/422848. Epub 2004 Aug 17. | |
| 20442456 | Background |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 8, 2016 | |
| Reset | Aug 18, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 8, 2016 | Aug 18, 2016 |
| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
|
Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels |
| Same as chemotherapy treatment (expected average of 6 months) |
| Levels of HIV-1 antibodies | Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels | Same as chemotherapy treatment (expected average of 6 months) |
| Percentage of CD4+ and CD8+ cells with immune activation markers | Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels | Same as chemotherapy treatment (expected average of 6 months) |
| Madrid |
| Madrid |
| 28046 |
| Spain |
| Moreno S, Mocroft A, Monforte Ad. Medical and societal consequences of late presentation. Antivir Ther. 2010;15 Suppl 1:9-15. doi: 10.3851/IMP1523. |
| 9371822 | Background | Chun TW, Stuyver L, Mizell SB, Ehler LA, Mican JA, Baseler M, Lloyd AL, Nowak MA, Fauci AS. Presence of an inducible HIV-1 latent reservoir during highly active antiretroviral therapy. Proc Natl Acad Sci U S A. 1997 Nov 25;94(24):13193-7. doi: 10.1073/pnas.94.24.13193. |
| 9360927 | Background | Finzi D, Hermankova M, Pierson T, Carruth LM, Buck C, Chaisson RE, Quinn TC, Chadwick K, Margolick J, Brookmeyer R, Gallant J, Markowitz M, Ho DD, Richman DD, Siliciano RF. Identification of a reservoir for HIV-1 in patients on highly active antiretroviral therapy. Science. 1997 Nov 14;278(5341):1295-300. doi: 10.1126/science.278.5341.1295. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |