Impact of MK-0518 (Raltegravir) Intensification on HIV-1 Viral Latency in Patients With Previous Complete Viral Suppression
|ClinicalTrials.gov Identifier: NCT00554398|
Recruitment Status : Completed
First Posted : November 6, 2007
Last Update Posted : November 13, 2009
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: MK-0518 400mg twice a day||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of MK-0518 (Raltegravir) Intensification on HIV-1 Viral Latency in Patients With Previous Complete Viral Suppression|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||September 2009|
MK-0518 400mg twice a day
Drug: MK-0518 400mg twice a day
Other Name: Raltegravir
No Intervention: B
- Quantification of integrated and unintegrated viral HIV-1 DNA in PBMCs [ Time Frame: Basal, week 12, week 24 and week 48 ]
- Quantification of residual HIV-1 (using an ultrasensitive RT-PCR assay with a lower limit of quantification of 5 copies/mL) [ Time Frame: 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) [ Time Frame: Basal, week 4, week 8, week 12, week 24, week 36 and week 48 ]
- Lymphocyte activation marker CD8+HLADR+CD38+ [ Time Frame: Basal, week 2, week 4, week 12, week 24 and week 48. ]
- Raltegravir plasma trough concentration. [ Time Frame: Week 12, week 24 and week 48 ]
- Level of apoptosis in CD4 and CD8 T cells. [ Time Frame: Week 48 and week 60 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554398
|Hospital Germans Trias i Pujol|
|Badalona, Barcelona, Spain, 08916|
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08025|
|Hospital Clínic I Provinical de Barcelona|
|Barcelona, Spain, 08036|
|Principal Investigator:||Martínez-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|
|Study Director:||Llibre Josep Mª, MD,PhD||Lluita contra la SIDA Foundation|