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Impact of MK-0518 (Raltegravir) Intensification on HIV-1 Viral Latency in Patients With Previous Complete Viral Suppression
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections | Drug: MK-0518 400mg twice a day | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Impact of MK-0518 (Raltegravir) Intensification on HIV-1 Viral Latency in Patients With Previous Complete Viral Suppression |
- 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 ]
| Enrollment: | 69 |
| Study Start Date: | November 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
MK-0518 400mg twice a day
|
Drug: MK-0518 400mg twice a day
Raltegravir, MK-0518
Other Name: Raltegravir
|
|
No Intervention: B
No intervention
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV-1 infected adults (+18 years old).
- Complete virological suppression (<50 copies/mL) for += 12 months, including at least 3 times during the last year.
- Patients on HAART regimen including a PI or an NNRTI and at least two nucleotide inhibitors.
- Voluntary written informed consent.
Exclusion Criteria:
- Pregnancy, or fertile women willing to be pregnant.
- Active substance abuse or major psychiatric disease.
- Presence of drug-related mutations or any polymorphism or mutation associated to MK-0518 resistance prior to first HAART (only if genotype is available).
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00554398
| Spain | |
| 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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | LLuita Sida Foundation |
| ClinicalTrials.gov Identifier: | NCT00554398 History of Changes |
| Other Study ID Numbers: |
INTEGRAL |
| Study First Received: | November 5, 2007 |
| Last Updated: | November 12, 2009 |
Keywords provided by Germans Trias i Pujol Hospital:
|
Raltegravir MK-0518 Treatment intensification |
HIV-1 latency HIV eradication treatment experienced |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Raltegravir Potassium Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 17, 2017