|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| 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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Crossover Assignment |
| Official Title: | A Phase II, Double Blind, Randomized, Exploratory Study of Chloroquine for Reducing HIV-Associated Immune Activation |
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
|
|
2: Experimental
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 | Recruiting |
| Birmingham, Alabama, United States, 35294-2050 | |
| Contact: Karen G. Savage 205-975-7925 kgsavage@uab.edu | |
| Principal Investigator: Victoria A. Johnson, MD | |
| United States, California | |
| Ucsd, Avrc Crs | Recruiting |
| San Diego, California, United States, 92103 | |
| Contact: Jill Kunkel 619-543-8080 jkunkel@ucsd.edu | |
| Principal Investigator: Constance A. Benson, MD | |
| UCLA Care Center | Recruiting |
| Los Angeles, California, United States, 90035 | |
| Contact: Maricela Gonzalez 310-557-3798 mmgonzalez@mednet.ucla.edu | |
| United States, Colorado | |
| University of Colorado Hospital CRS | Not yet recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Mary Graham 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) | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Abimael Lopez 202-687-7387 al374@georgetown.edu | |
| Principal Investigator: Princy N. Kumar, MD | |
| United States, Illinois | |
| Northwestern University CRS | Not yet recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Baiba Berzins, MPH 312-695-4994 Baiba@northwestern.edu | |
| Principal Investigator: Babafemi O. Taiwo, MD | |
| United States, Maryland | |
| Johns Hopkins Adult AIDS CRS | Not yet recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Ilene Wiggins, RN 410-614-2766 imp@jhmi.edu | |
| Principal Investigator: Charles Flexner, MD | |
| United States, New York | |
| NY Univ. HIV/AIDS CRS | Active, not recruiting |
| New York, New York, United States, 10016 | |
| Cornell CRS | Recruiting |
| New York, New York, United States, 10011 | |
| Contact: Todd Stroberg, RN, BSN 212-746-7198 tstrober@med.cornell.edu | |
| Principal Investigator: Timothy J. Wilkin, MD | |
| United States, Ohio | |
| MetroHealth CRS | Not yet recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Contact: Ann Conrad, RN, ACRN 216-778-5489 aconrad@metrohealth.org | |
| Principal Investigator: Robert C Kalayjian, MD | |
| Case CRS | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Jane Baum, RN 216-844-2546 baum.jane@clevelandactu.org | |
| Principal Investigator: Michael M. Lederman, MD | |
| Univ. of Cincinnati CRS | Not yet recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Tammy Mansfield, R.N., A.C.R.N. 1-513-584-8373 mansfitl@ucmail.uc.edu | |
| United States, Pennsylvania | |
| Hosp. of the Univ. of Pennsylvania CRS | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Joseph Quinn, RN 215-349-8092 joseph.quinn@uphs.upenn.edu | |
| Principal Investigator: Pablo Tebas, MD | |
| United States, Tennessee | |
| Vanderbilt Therapeutics CRS | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Deborah Sutherland 615-467-0154 ext 109 deborah.sutherland@vanderbilt.edu | |
| Principal Investigator: David W Haas, MD | |
More Information
| Responsible Party: | DAIDS ( Rona Siskind ) |
| Study ID Numbers: | ACTG A5258 |
| Study First Received: | January 8, 2009 |
| Last Updated: | February 4, 2010 |
| ClinicalTrials.gov Identifier: | NCT00819390 History of Changes |
| Health Authority: | United States: Federal Government |
|
Anti-Inflammatory Agents Anti-Infective Agents Sexually Transmitted Diseases, Viral Antiprotozoal Agents Slow Virus Diseases Physiological Effects of Drugs Infection Antimalarials Antiparasitic Agents Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Amebicides Analgesics Retroviridae Infections |
Antinematodal Agents RNA Virus Infections Immune System Diseases Filaricides Acquired Immunodeficiency Syndrome Chloroquine Anthelmintics Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Analgesics, Non-Narcotic Chloroquine diphosphate Sexually Transmitted Diseases Lentivirus Infections |