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| Sponsor: | AIDS Clinical Trials Group |
|---|---|
| Collaborator: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by (Responsible Party): | AIDS Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00819390 |
Purpose
HIV is characterized by frequent immune system activation. Early in the course of infection the body establishes an immune activation "set point" related to the amount of HIV in the blood stream. This set point affects the rate of CD4 cell loss. Without CD4 cells, or with very low levels of CD4 cells, the body cannot fight off illness. This is known as immunodeficiency. If left untreated HIV can lead to extreme immunodeficiency and AIDS.
Evidence suggests that by decreasing the rate of immune system activation, immune deficiency progression could be prevented. The purpose of this study is to learn how well chloroquine can reduce the level of immune activation and to test the safety and tolerance of chloroquine in people infected with HIV.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Chloroquine Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | A Phase II, Double Blind, Randomized, Exploratory Study of Chloroquine for Reducing HIV-Associated Immune Activation |
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive chloroquine from Day 0 through the Week 12 study visit. Participants will then change to placebo treatment until the Week 24 study visit.
|
Drug: Chloroquine
Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Drug: Placebo
Taken orally, once daily for 12 weeks.
|
|
Experimental: 2
Participants will receive a chloroquine placebo treatment from Day 0 through the Week 12 study visit. Participants will then begin treatment with chloroquine until the Week 24 study visit.
|
Drug: Chloroquine
Taken orally, once daily, at a dose of 250 mg for 12 weeks.
Drug: Placebo
Taken orally, once daily for 12 weeks.
|
HIV is characterized by persistent immune system activation, and early in the course of infection the body establishes an immune activation "set point" related to the amount of HIV in the blood stream. This set point affects the rate of CD4 cell loss. Without CD4 cells, or with very low levels of CD4 cells, the body cannot fight off illness. This is known as immunodeficiency. If left untreated HIV can lead to extreme immunodeficiency and AIDS.
Immune system activation includes activating the CD8 cells. These cells attack body cells infected with viruses. Because of this, CD4 cells infected with HIV are frequently destroyed by CD8 cells. The purpose of this study is to learn how well chloroquine reduces the level of activation of CD8 cells in people infected with HIV. Increased activation of CD8 cells is thought to lead to a more severe path of disease in HIV infection.
The constant immune activation observed in HIV- infected patients has also been linked to higher levels of byproducts from certain naturally occurring bacteria found in the gut that are known to be immune stimulants. By decreasing the stimulation from these byproducts with chloroquine treatment, HIV disease may be slowed.
The purpose of this study is to learn how well chloroquine reduces the level of activation of CD8 cells and lowers the levels of bacteria byproducts in people infected with HIV. This study will also look at how well chloroquine is tolerated and its safety in HIV- infected patients.
Participants in this study will be randomly assigned to one of two treatment arms:
Arm A: Participants will receive 12 weeks of chloroquine treatment followed by 12 weeks of placebo
Arm B: Participants will receive 12 weeks of placebo followed by 12 weeks of chloroquine
Study treatment will be given once a day for a full 24 weeks. There will be an additional 4 weeks of follow-up for purposes of safety. After treatment has started, participants will be asked to come to the clinic on Weeks 4, 10, 12, 16, 22, and 24. At each visit participants will receive enough study treatment to last until the next visit. Each visit will last between 30 and 60 minutes. At most visits participants will have a physical exam, answer questions about any medications they are taking and how they are feeling, and have blood drawn for safety to assess CD4/CD8 cell counts and viral load. Some additional blood will also be stored for immunology testing. At some visits participants will be asked questions about their medication and medical history, have pupils dilated, have a hearing test, and have an electrocardiogram (EKG). Some visits will require participants to arrive fasting. Pregnancy tests may also be conducted if the participant is able to become pregnant or if pregnancy is suspected.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| Alabama Therapeutics CRS (5801) | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Karen Savage, BSN 205-975-7925 kgsavage@uab.edu | |
| Principal Investigator: Victoria Johnson, MD | |
| United States, Colorado | |
| University of Colorado Hospital CRS (6101) | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Mary G Ray, RN, MSN 303-724-0712 graham.ray@uchsc.edu | |
| Principal Investigator: Thomas B Campbell, MD | |
| United States, District of Columbia | |
| Georgetown University CRS (GU CRS) (1008) | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Max Menna 202-687-6845 mpm229@goergetown.edu | |
| Principal Investigator: Princy N. Kumar, MD | |
| United States, Maryland | |
| Johns Hopkins Adult AIDS CRS (201) | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Contact: Ilene Wiggins, RN 410-614-2766 iwiggin1@jhmi.edu | |
| Principal Investigator: Charles Flexner, MD | |
| United States, Massachusetts | |
| Massachusetts General Hospital ACTG CRS (101) | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Teri Flynn, RN, ANP, MSN 617-724-0072 tflynn@partners.org | |
| Principal Investigator: Rajesh Gandhi, MD | |
| United States, Missouri | |
| Washington University CRS (2101) | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Michael Klebert, RNC, PhD, ANP 1-314-747-1098 mklebert@im.wustl.edu | |
| Principal Investigator: Edgar T. Overton, MD | |
| United States, New York | |
| Cornell CRS (7804) | Recruiting |
| New York, New York, United States, 10011 | |
| Contact: Todd Stroberg, R.N., B.S.N. 212-746-7198 tstrober@med.cornell.edu | |
| United States, North Carolina | |
| Unc Aids Crs (3201) | Recruiting |
| Chapel Hill, North Carolina, United States, 27514 | |
| Contact: Cheryl J. Marcus, BSN, RN 919-843-8761 cjm@med.unc.edu | |
| Principal Investigator: David A. Wohl, MD | |
| United States, Ohio | |
| Univ. of Cincinnati CRS (2401) | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Tammy Mansfield, RN 513-584-8373 mansfitl@ucmail.uc.edu | |
| Principal Investigator: Judith Feinberg, MD | |
| MetroHealth CRS (2503) | Recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Contact: Julie Ziegler, MS 216-778-7847 jziegler@metrohealth.org | |
| Principal Investigator: Robert C. Kalayjian, MD | |
| Case CRS (2501) | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Jane Baum, BSN, RN 216-844-2546 baum.jane@clevelandactu.org | |
| Principal Investigator: Michael Lederman, MD | |
| United States, Pennsylvania | |
| Hosp. of the Univ. of Pennsylvania CRS (6201) | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Joseph Quinn, RN 215-349-8091 joseph.quinn@uphs.upenn.edu | |
| Principal Investigator: Pablo Tebas, MD | |
| Pittsburgh CRS (1001) | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Christine Tripoli, BSN, RN 412-647-0771 tripolica@upmc.edu | |
| Principal Investigator: Sharon Riddler, MD, MPH | |
| United States, Tennessee | |
| Vanderbilt Therapeutics CRS (3652) | Recruiting |
| Nashville, Tennessee, United States, 37204 | |
| Contact: Deborah D Sutherland, RN, BSN, CCRP (615) 936-8516 deborah.sutherland@vanderbilt.edu | |
| Principal Investigator: David Haas, MD | |
| Study Chair: | Jeffrey M Jacobson, MD | Drexel University College of Medicine |
More Information
| Responsible Party: | AIDS Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00819390 History of Changes |
| Other Study ID Numbers: | ACTG A5258, 1U01AI068636 |
| Study First Received: | January 8, 2009 |
| Last Updated: | February 16, 2012 |
| Health Authority: | United States: Federal Government |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Chloroquine Chloroquine diphosphate Amebicides Antiprotozoal Agents |
Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimalarials Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Filaricides Antinematodal Agents |