NCT00308620

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started Mar 2006

Typical duration for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

August 17, 2012

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

2.8 years

First QC Date

March 27, 2006

Results QC Date

September 26, 2011

Last Update Submit

June 2, 2020

Conditions

HIV Infections

Keywords

HIVchloroquinedisease progressioninflammationtreatment naive

Outcome Measures

Primary Outcomes (1)

  • HIV Viral Load Change

    HIV-1 viral load change between baseline and 8 weeks

    baseline and 8 weeks

Secondary Outcomes (1)

  • Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks

    8 weeks

Study Arms (2)

Chloroquine

EXPERIMENTAL

Chloroquine 205mg or 500mg orally once daily (Results pooled)

Drug: chloroquine phosphate

Placebo

PLACEBO COMPARATOR

Placebo once daily for 8 weeks

Drug: Placebo

Interventions

chloroquine phosphateDRUG

250mg or 500mg PO (by mouth) QDay

Also known as: Aralen
Chloroquine
PlaceboDRUG

Placebo once daily for 8 weeks

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior retinal eye disease
  • CD4 \< 250 cells/µL
  • Renal failure
  • Active malignancy
  • Corticosteroid therapy
  • Age \< 18 or \> 65 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minnesota ACTU

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • Murray SM, Down CM, Boulware DR, Stauffer WM, Cavert WP, Schacker TW, Brenchley JM, Douek DC. Reduction of immune activation with chloroquine therapy during chronic HIV infection. J Virol. 2010 Nov;84(22):12082-6. doi: 10.1128/JVI.01466-10. Epub 2010 Sep 15.

    PMID: 20844049RESULT

Related Links

MeSH Terms

Conditions

HIV InfectionsDisease ProgressionInflammation

Interventions

chloroquine diphosphateChloroquine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
David Boulware
Organization
University of Minnesota
boulw001@umn.edu
6126269546

Study Officials

  • David R Boulware, MD, MPH

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2006

First Posted

March 29, 2006

Study Start

March 1, 2006

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

June 4, 2020

Results First Posted

August 17, 2012

Record last verified: 2020-06

Locations

US(1)