HIV InfectionsPhase 2/3NCT00308620
Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine
A Phase 2/3 study testing chloroquine phosphate in people with HIV Infections, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- chloroquine phosphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jun 2009
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior retinal eye disease
- CD4 < 250 cells/µL
- Renal failure
- Active malignancy
- Corticosteroid therapy
- Age < 18 or > 65 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Pilot Study of the Anti-Viral and Anti-Inflammatory Effects of Chloroquine in Early HIV Infection
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.
Read the 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).
- Conditions
- HIV Infections
- Being tested
- chloroquine phosphate, Placebo
- Keywords
- HIV, chloroquine, disease progression, inflammation, treatment naive
- Medical subject headings
- HIV Infections, Disease Progression, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chloroquine phosphateDrug
Also called Aralen
250mg or 500mg PO (by mouth) QDay
PlaceboDrug
Placebo once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Chloroquine | Experimental | Chloroquine 205mg or 500mg orally once daily (Results pooled) Receives: Drug: chloroquine phosphate |
| Placebo | Placebo comparator | Placebo once daily for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Viral Load Change
HIV-1 viral load change between baseline and 8 weeks
Measured: baseline and 8 weeks
Secondary outcomes (1)
Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks
The Change in the percentages of CD38+ HLA-DR+ CD8 and CD4 memory T cells from baseline to 8 weeks.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2008
- Study completionJun 2009
Why it stopped: Insufficient financial support; lack of efficacy for primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Minnesota Medical Foundation
- Responsible party
- Sponsor
- Investigators
- David R Boulware, MD, MPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308620
- Sponsor's protocol ID
- 0510M77007
- Status last verified
- Jun 2020
- First submitted
- 27 Mar 2006
- Last updated
- 4 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20844049
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Pilot Study of the Anti-Viral and Anti-Inflammatory Effects of Chloroquine in Early HIV Infection
- ClinicalTrials.gov ID
- NCT00308620
- Acronym / sponsor ID
- 0510M77007
- Conditions
- HIV Infections
- Keywords
- HIV, chloroquine, disease progression, inflammation, treatment naive
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient financial support; lack of efficacy for primary endpoint
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Minnesota Medical Foundation
- Study start
- Mar 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 Mar 2006 (estimated)
- Results
- Posted 17 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chloroquine | Experimental | Drug: chloroquine phosphateChloroquine 205mg or 500mg orally once daily (Results pooled) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once daily for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Prior retinal eye disease
- CD4 < 250 cells/µL
- Renal failure
- Active malignancy
- Corticosteroid therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chloroquine phosphateAlso: Aralen250mg or 500mg PO (by mouth) QDay | Drug | Chloroquine |
| PlaceboPlacebo once daily for 8 weeks | Drug | Placebo |
Primary outcome
HIV Viral Load Change
Time frame: baseline and 8 weeks
HIV-1 viral load change between baseline and 8 weeks
1 secondary outcome
Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20844049Murray 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.
- University of Minnesota Clinical Virology ProgramLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Boulware, MD, MPH principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing chloroquine phosphate in people with HIV Infections, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Viral Load Change (time frame: baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00308620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.