Integrase Inhibitor (MK-0518) Viral Decay - Full Text View

Sponsors and Collaborators:	Canadian Immunodeficiency Research Collaborative National Institutes of Health (NIH)
Information provided by:	Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier:	NCT00520897

Purpose

The eradication of HIV by antiretroviral therapy has thus far been elusive. It has been consistently demonstrated that a pool of latently infected, resting CD4+ T cells persists in the majority of HIV-infected individuals receiving antiretroviral therapy in whom plasma viremia has been successfully suppressed for prolonged periods of time; this pool has emerged as the major obstacle in achieving the eradication of HIV. We believe that MK-0518 can further the decay and suppression of HIV-1 in patients who have been virologically suppressed for a prolonged period of time on effective cART (≥ 4 years).

Condition	Intervention	Phase
HIV Infections	Drug: Raltegravir (MK0518) Drug: Placebo Procedure: Leukopheresis Procedure: Sigmoid Biopsy	Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Raltegravir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment
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

Further study details as provided by Canadian Immunodeficiency Research Collaborative:

Estimated Enrollment:

30

Arms	Assigned Interventions
MK0518 + cART: Experimental Raltegravir + standard of care combined antiretroviral therapy	Drug: Raltegravir (MK0518) 400mg BID; 48 weeks Procedure: Leukopheresis Procedure: Sigmoid Biopsy
Placebo + cART: Placebo Comparator Placebo + standard of care combined antiretroviral therapy	Drug: Placebo Procedure: Leukopheresis Procedure: Sigmoid Biopsy

Detailed Description:

The trial is a prospective, double-blind, randomized, placebo-controlled study with two phases: phase I to 48 weeks and phase II to 96 weeks with the primary analysis at 48 weeks. HIV-infected individuals who are taking their first standard cART regimen for at least four years with complete viral suppression. Upon enrollment, he/she will be randomized to one of two arms: the MK-0518 arm or the control arm. As each participant reaches week 48, he/she will be unblinded and those in the MK-0518 arm will continue taking MK-0518. Based on the results of an interim analysis, the control arm will be rolled over to receive MK-0518 for 48 weeks. After the screening, baseline visits and week 4 safety visit, follow-up visits will occur every 8 weeks for both arms.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520897

Contacts

Contact: Desmond Persad, M.Sc.	416-465-0856 ext 226	desmond.persad@mapleleafmedical.com
Contact: Roberta Halpenny, B.Sc	416-465-7936	rhalpenny@on.aibn.com

Locations

Canada, Ontario
Maple Leaf Medical Clinic
Toronto, Ontario, Canada, M5B 1L6

Sponsors and Collaborators

Canadian Immunodeficiency Research Collaborative

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Mona Loutfy, MD

Women's College Hospital

More Information

Study ID Numbers:	038-00
Study First Received:	August 24, 2007
Last Updated:	September 4, 2007
ClinicalTrials.gov Identifier:	NCT00520897
Health Authority:	Canada: Health Canada

Keywords provided by Canadian Immunodeficiency Research Collaborative:

chronic HIV infection
Human Immunodeficiency Virus
Treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Slow Virus Diseases

Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009