Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine
Study Details
Study Description
Brief Summary
Summary: Chloroquine is a medication that in laboratory settings has significant anti-HIV effects in HIV infected T-cells. Chloroquine has been used safely for over 60 years for malaria treatment and prevention, and it also has significant anti-inflammatory effects. No formal study of chloroquine has been performed in people with HIV infection. Chloroquine is used worldwide and is quite inexpensive outside of the United States. If shown to be effective, chloroquine could be a very important tool worldwide in delaying HIV disease progression which would extend the time period without needing anti-retroviral therapy. In countries where anti-retroviral therapy is not available, this could be very helpful.
This is an 8 week trial study requiring 3 study visits. Participants will be ask to take a once a day study medication (chloroquine or placebo) for 8 weeks and have three blood draws for CD4 counts, HIV viral loads, and other research tests. The visits are at study enrollment, 4 weeks, and 8 weeks.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
Summary:
A phase I randomized, double-blind, placebo controlled trial to investigate the efficacy of chloroquine to decrease T-cell activation and decrease viral load in early HIV.
Scientific Rationale:
Chloroquine has in vivo direct anti-HIV effects and an anti-inflammatory effect. These properties may be beneficial in reducing viral burden and immune activation therefore delaying HIV disease progression.
Sample Size: 25
Length of Study: 8 weeks, [enrollment + 2 follow up visits].
Intervention:
-
Arm 1a: Chloroquine 250mg orally once daily for 8 weeks.
-
Arm 1b: Chloroquine 500mg orally once daily for 8 weeks.
-
Arm 2: Placebo once daily for 8 weeks.
Measurements:
-
Blood draws at weeks: 0, 4, and 8 weeks.
-
CD4, viral load measurements will be communicated to the referring provider (with subject consent).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Chloroquine Chloroquine 205mg or 500mg orally once daily (Results pooled) |
Drug: chloroquine phosphate
250mg or 500mg PO (by mouth) QDay
Other Names:
|
Placebo Comparator: Placebo Placebo once daily for 8 weeks |
Drug: Placebo
Placebo once daily for 8 weeks
|
Outcome Measures
Primary Outcome Measures
- HIV Viral Load Change [baseline and 8 weeks]
HIV-1 viral load change between baseline and 8 weeks
Secondary Outcome Measures
- Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks [8 weeks]
The Change in the percentages of CD38+ HLA-DR+ CD8 and CD4 memory T cells from baseline to 8 weeks.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
HIV-1 infected adults
-
CD4 count > 250 cells/mm3
-
Not presently receiving HIV antiretroviral therapy (> 6 months or naïve)
-
Viral load > 3000 RNA copies/mL (3.5 log)
-
No planned HIV anti-retroviral therapy for 8 weeks
Exclusion Criteria:
-
Prior retinal eye disease
-
CD4 < 250 cells/µL
-
Renal failure
-
Active malignancy
-
Corticosteroid therapy
-
Age < 18 or > 65 years
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Minnesota ACTU | Minneapolis | Minnesota | United States | 55455 |
Sponsors and Collaborators
- University of Minnesota
- Minnesota Medical Foundation
Investigators
- Principal Investigator: David R Boulware, MD, MPH, University of Minnesota
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 0510M77007
Study Results
Participant Flow
Recruitment Details | 2006-2008 recruitment of volunteers in HIV care but electing to not receive ART. |
---|---|
Pre-assignment Detail |
Arm/Group Title | Chloroquine 500mg | Placebo | Chloroquine 250mg |
---|---|---|---|
Arm/Group Description | Chloroquine 500mg PO once daily x 8 weeks | Placebo once daily for 8 weeks | Chloroquine 250mg PO once daily x 8 weeks |
Period Title: Overall Study | |||
STARTED | 3 | 4 | 6 |
COMPLETED | 2 | 3 | 5 |
NOT COMPLETED | 1 | 1 | 1 |
Baseline Characteristics
Arm/Group Title | Chloroquine 500mg | Placebo | Chloroquine 250mg | Total |
---|---|---|---|---|
Arm/Group Description | Chloroquine 500mg PO once daily x 8 weeks | Placebo once daily for 8 weeks | Chloroquine 250mg PO once daily x 8 weeks | Total of all reporting groups |
Overall Participants | 3 | 4 | 6 | 13 |
Age (Count of Participants) | ||||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
3
100%
|
4
100%
|
6
100%
|
13
100%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
40
(15)
|
34
(5)
|
36
(5)
|
36.5
(8.0)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
0
0%
|
1
25%
|
0
0%
|
1
7.7%
|
Male |
3
100%
|
3
75%
|
6
100%
|
12
92.3%
|
Region of Enrollment (participants) [Number] | ||||
United States |
3
100%
|
4
100%
|
6
100%
|
13
100%
|
Outcome Measures
Title | HIV Viral Load Change |
---|---|
Description | HIV-1 viral load change between baseline and 8 weeks |
Time Frame | baseline and 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Chloroquine 250mg or 500mg | Placebo |
---|---|---|
Arm/Group Description | Chloroquine 250mg or 500mg orally once daily x 8 weeks. n=6 for 250mg; n=3 for 500mg | Placebo orally once daily for 8 weeks |
Measure Participants | 9 | 4 |
Log Mean (Standard Deviation) [log10 copies/mL] |
-.083
(.5)
|
0.0
(.1)
|
Title | Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks |
---|---|
Description | The Change in the percentages of CD38+ HLA-DR+ CD8 and CD4 memory T cells from baseline to 8 weeks. |
Time Frame | 8 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Analysis of Chloroquine arms is pooled. |
Arm/Group Title | Chloroquine 250mg or 500mg | Placebo |
---|---|---|
Arm/Group Description | Chloroquine 500mg orally once daily x 8 weeks | Placebo orally once daily for 8 weeks |
Measure Participants | 7 | 3 |
CD8 CD38+HLA-DR+ |
-2.5
|
1.85
|
CD4 ki67+ |
-2.0
|
1.4
|
Adverse Events
Time Frame | ||||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | Chloroquine 500mg | Placebo | Chloroquine 250mg | |||
Arm/Group Description | Chloroquine 500mg PO once daily x 8 weeks | Placebo once daily for 8 weeks | Chloroquine 250mg PO once daily x 8 weeks | |||
All Cause Mortality |
||||||
Chloroquine 500mg | Placebo | Chloroquine 250mg | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
Chloroquine 500mg | Placebo | Chloroquine 250mg | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/3 (33.3%) | 1/4 (25%) | 0/6 (0%) | |||
Social circumstances | ||||||
Death (non-related) | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 0/6 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
Chloroquine 500mg | Placebo | Chloroquine 250mg | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | David Boulware |
---|---|
Organization | University of Minnesota |
Phone | 6126269546 |
boulw001@umn.edu |
- 0510M77007