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| Name | Class |
|---|---|
| FundaciĂłn FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la PromociĂłn de la Salud y la Ciencia | OTHER |
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An intensification with the HIV-1 integrase inhibitor Raltegravir (RAL) of a stable HAART regimen with persistent HIV-1 viral suppression could increase the slope of decay of the HIV-1 latent reservoir.
While highly active antiretroviral therapy (HAART) reduces plasma HIV-1 levels to below the limits of detection with standard assays, replication-competent virus persist in a stable, latent reservoir in resting CD4+ T cells. So, there is a rapid resumption in plasma viremia when therapy is interrupted.
In addition to cellular reservoir, other pharmacologically privileged areas such as the central nervous system and the genital tract might act as additional sources of residual virus in patients with undetectable levels of plasma HIV-1 RNA. There is great current interest in strategies for depleting and eliminating this reservoir.
The antiviral potency of current regimens emerges as an important determinant of complete viral control. In certain patients, the latent reservoir decay can be hastened with treatment intensification.
An intensification with the HIV-1 integrase inhibitor Raltegravir (RAL) of a stable HAART regimen with persistent HIV-1 viral suppression could increase the slope of decay of the HIV-1 latent reservoir. This could provide further insight into this area, decrease the size of latent reservoir, and translate into clinical benefits for patients being simplified to maintenance monotherapy with RAL or in the HIV-1 rebound kinetics and slope after a programmed treatment interruption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | MK-0518 400mg twice a day |
|
| B | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-0518 400mg twice a day | Drug | Raltegravir, MK-0518 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of integrated and unintegrated viral HIV-1 DNA in PBMCs | Basal, week 12, week 24 and week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of residual HIV-1 (using an ultrasensitive RT-PCR assay with a lower limit of quantification of 5 copies/mL) | Basal, week 1, week 2, week 4, week 8, week 12, week 24, week 36 and week 48 | |
| Blips during the study (> 50 copies/mL, preceded and followed by determinations < 50 copies/mL in previous and posterior controls) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MartĂnez-Picado Javier, MD,PhD | Irsi Caixa -Hospital Germans Trias i Pujol | Principal Investigator |
| Paredes Roger, MD,PhD | Lluita contra la Sida Foundation | Principal Investigator |
| Clotet Bonaventura, MS,PhD | Lluita contra la Sida Foundation | Principal Investigator |
| Llibre Josep MÂŞ, MD,PhD | Lluita contra la SIDA Foundation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Hospital de la Santa Creu i Sant Pau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22290239 | Derived | Llibre JM, Buzon MJ, Massanella M, Esteve A, Dahl V, Puertas MC, Domingo P, Gatell JM, Larrouse M, Gutierrez M, Palmer S, Stevenson M, Blanco J, Martinez-Picado J, Clotet B. Treatment intensification with raltegravir in subjects with sustained HIV-1 viraemia suppression: a randomized 48-week study. Antivir Ther. 2012;17(2):355-64. doi: 10.3851/IMP1917. Epub 2011 Sep 28. |
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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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| Basal, week 4, week 8, week 12, week 24, week 36 and week 48 |
| Lymphocyte activation marker CD8+HLADR+CD38+ | Basal, week 2, week 4, week 12, week 24 and week 48. |
| Raltegravir plasma trough concentration. | Week 12, week 24 and week 48 |
| Level of apoptosis in CD4 and CD8 T cells. | Week 48 and week 60 |
| Barcelona |
| 08025 |
| Spain |
| Hospital ClĂnic I Provinical de Barcelona | Barcelona | 08036 | Spain |
| 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 |