Integrase Inhibitor (MK-0518) Viral Decay
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ClinicalTrials.gov Identifier: NCT00520897 |
Recruitment Status
:
Completed
First Posted
: August 27, 2007
Last Update Posted
: June 5, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Raltegravir (MK0518) Drug: Placebo Procedure: Leukopheresis Procedure: Sigmoid Biopsy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effect of Integrase Inhibitor (MK-0518) on Decay of Low Level Viral Replication in HIV Reservoirs in Infected Individuals Who Initiated Conventional Antiretroviral Therapy During the Chronic Phase of Infection |
Study Start Date : | April 2007 |
Actual Primary Completion Date : | February 2009 |
Actual Study Completion Date : | November 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: MK0518 + cART
Raltegravir + standard of care combined antiretroviral therapy
|
Drug: Raltegravir (MK0518)
400mg BID; 48 weeks
Procedure: Leukopheresis
pack of cells as per protocol
Procedure: Sigmoid Biopsy
gut samples as per protocol
|
Placebo Comparator: Placebo + cART
Placebo + standard of care combined antiretroviral therapy
|
Drug: Placebo
400mg QD
Procedure: Leukopheresis
pack of cells as per protocol
Procedure: Sigmoid Biopsy
gut samples as per protocol
|
- change of proviral HIV-1 DNA in total CD4+ T cells from baseline to week 48 [ Time Frame: 48 weeks ]evaluate the change of proviral HIV-1 DNA in total CD4+ T cells from baseline to week 48 in participants randomized to the raltegravir arm (400mg raltegravir) for 48 weeks in addition to their current standard combination antiretroviral regimen versus the control arm, who remained on their current standard combination antiretroviral regimen.
- evaluated the effect of raltegravir intensification on blood CD4+ T cell populations [ Time Frame: 48 & 96 weeks ]evaluated the effect of raltegravir intensification on blood CD4+ T cell populations. In addition, after treatment-intensification in both groups at week 48, a post-hoc follow-up of all participants was conducted up to week 96 to examine if raltegravir intensification had any long-term effects on proviral HIV DNA and CD4+ T cell populations in the blood and gut.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participant must be HIV-1 infected
- Participant must be 18 years old
- Participant must be taking first standard cART with 2-3 NRTIs and 1-2 PIs or an NNRTI for at least four years (first cART regimen may include changes due to toxicity but not due to virologic failure).
- Participant must have a VL < 50 copies/ml (using the standard available methods of detection) during the entire time on standard cART except for initial fall of VL and a maximum of two non-consecutive blips of < 100 copies/ml that the study investigator deems to be not clinically significant
- Female participant must agree to use two methods of birth control or abstinence during the period of the study
- Participant has to have signed full informed consent
Exclusion Criteria:
- Participant who would have difficulty participating in a trial due to non-adherence or substance abuse
- Participant who has taken mono or dual antiretroviral therapy in the past
- Participant who has had a VL > 50 copies/ml on any antiretroviral regimen
-
Participant with any of the following abnormal laboratory test results in screening:
- Hemoglobin < 100 g/L
- Neutrophil count < 750 cells/L
- Platelet count < 50,000 cells/L
- AST or ALT > 5X the upper limit of normal
- Creatinine > 250 mol/L
- Participant with a malignancy
- Participant with other significant underlying disease (non-HIV) that might impinge upon disease progression or death
- Participant with an active AIDS-defining illness in the past six months
- Participant who is pregnant

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): NCT00520897
Canada, Ontario | |
Maple Leaf Medical Clinic | |
Toronto, Ontario, Canada, M5B 1L6 |
Principal Investigator: | Mona Loutfy, MD | Women's College Hospital |
Responsible Party: | Canadian Immunodeficiency Research Collaborative |
ClinicalTrials.gov Identifier: | NCT00520897 History of Changes |
Other Study ID Numbers: |
038-00 |
First Posted: | August 27, 2007 Key Record Dates |
Last Update Posted: | June 5, 2012 |
Last Verified: | June 2012 |
Keywords provided by Canadian Immunodeficiency Research Collaborative:
chronic HIV infection Human Immunodeficiency Virus Treatment Experienced |
Additional relevant MeSH terms:
Infection 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 Integrase Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |