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Short-term Disulfiram Administration to Reverse Latent HIV Infection: a Dose Escalation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01944371
Recruitment Status : Completed
First Posted : September 17, 2013
Results First Posted : May 5, 2020
Last Update Posted : May 5, 2020
Sponsor:
Collaborators:
Monash University
amfAR, The Foundation for AIDS Research
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Steven Deeks, University of California, San Francisco

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions HIV
Human Immunodeficiency Virus
Intervention Drug: Disulfiram
Enrollment 30
Recruitment Details Of 34 participants screened for eligibility, we recruited 30 participants at The Alfred Hospital (Melbourne, VIC, Australia) and the San Francisco General Hospital (San Francisco, CA, USA) between September 24, 2013, and March 31, 2014.
Pre-assignment Details  
Arm/Group Title Disulfiram 500mg Disulfiram 1000mg Disulfiram 2000mg
Hide Arm/Group Description

500mg disulfiram by mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

1000mg disulfiram by mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

2000mg disulfiram per mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

Period Title: Overall Study
Started 10 10 10
Completed 10 10 10
Not Completed 0 0 0
Arm/Group Title Disulfiram 500mg Disulfiram 1000mg Disulfiram 2000mg Total
Hide Arm/Group Description

500mg disulfiram by mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

1000mg disulfiram by mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

2000mg disulfiram per mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

Total of all reporting groups
Overall Number of Baseline Participants 10 10 10 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 10 participants 30 participants
53
(34 to 63)
54
(40 to 65)
51
(26 to 67)
53
(26 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 30 participants
Female
1
  10.0%
0
   0.0%
1
  10.0%
2
   6.7%
Male
9
  90.0%
10
 100.0%
9
  90.0%
28
  93.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
  10.0%
1
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  40.0%
1
  10.0%
1
  10.0%
6
  20.0%
White
6
  60.0%
9
  90.0%
7
  70.0%
22
  73.3%
More than one race
0
   0.0%
0
   0.0%
1
  10.0%
1
   3.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 30 participants
United States 4 6 5 15
Australia 6 4 5 15
1.Primary Outcome
Title Cell-associated HIV RNA
Hide Description Fold change cell-associated HIV RNA in Total CD4 T-Cells.
Time Frame Baseline and 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Disulfiram 500mg Disulfiram 1000mg Disulfiram 2000mg
Hide Arm/Group Description:

500mg disulfiram by mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

1000mg disulfiram by mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

2000mg disulfiram per mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

Overall Number of Participants Analyzed 10 10 10
Mean (95% Confidence Interval)
Unit of Measure: Fold change
1.7
(1.3 to 2.2)
1.9
(1.6 to 2.4)
1.6
(1.2 to 2.1)
2.Secondary Outcome
Title Plasma HIV RNA
Hide Description Fold change in plasma HIV RNA levels from baseline through day 3
Time Frame Baseline and 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Disulfiram 500mg Disulfiram 1000mg Disulfiram 2000mg
Hide Arm/Group Description:

500mg disulfiram by mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

1000mg disulfiram by mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

2000mg disulfiram per mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

Overall Number of Participants Analyzed 10 10 10
Mean (Full Range)
Unit of Measure: Fold change
1.50
(0.36 to 3.4)
0.90
(0.18 to 1.7)
1.22
(0.32 to 2.83)
3.Secondary Outcome
Title Proviral HIV DNA
Hide Description Fold change in HIV DNA levels between Baseline and Day 30
Time Frame Baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Disulfiram 500mg Disulfiram 1000mg Disulfiram 2000mg
Hide Arm/Group Description:

500mg disulfiram by mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

1000mg disulfiram by mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

2000mg disulfiram per mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

Overall Number of Participants Analyzed 10 10 10
Mean (95% Confidence Interval)
Unit of Measure: Fold change
1.07
(0.89 to 1.28)
0.83
(0.60 to 1.15)
0.91
(0.77 to 1.05)
4.Other Pre-specified Outcome
Title Disufiram Pharmacokinetics
Hide Description Plasma concentrations of disulfiram were measured on dosing day 1 (hours 0, 2, and 6), day 2 (hour 0), and day 3 (hours 0, 2, and 6), as well as on postdosing days 4, 8, and 31. The area under the curve (AUC) levels over 72 hours was estimated.
Time Frame 31 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Disulfiram 500mg Disulfiram 1000mg Disulfiram 2000mg
Hide Arm/Group Description:

500mg disulfiram by mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

1000mg disulfiram by mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

2000mg disulfiram per mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

Overall Number of Participants Analyzed 10 10 10
Mean (97.5% Confidence Interval)
Unit of Measure: mg-hour/liter
3,186
(3,140 to 3,281)
8,386
(7,149 to 12,861)
22,331
(18,481 to 35,102)
Time Frame Subjects were monitored in an outpatient clinic during the first 6 hours post-dose on days 1 and 3. At each visit, subjects were assessed for any new symptoms and vital signs. A complete blood count and complete metabolic panel were performed during screening, and then at Days 1, 2, 3, 4, 8 and 31. No evaluations were made after Day 31.
Adverse Event Reporting Description The grading system for drug toxicities is located in the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification, August 2009), which can be found on the DAIDS RSC Web Site (http://rsc.tech-res.com/safetyandpharmacovigilance/.)
 
Arm/Group Title Disulfiram 500mg Disulfiram 1000mg Disulfiram 2000mg
Hide Arm/Group Description

500mg disulfiram by mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

1000mg disulfiram by mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

2000mg disulfiram per mouth per day for 3 days

Disulfiram: This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.

All-Cause Mortality
Disulfiram 500mg Disulfiram 1000mg Disulfiram 2000mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Hide Serious Adverse Events
Disulfiram 500mg Disulfiram 1000mg Disulfiram 2000mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Disulfiram 500mg Disulfiram 1000mg Disulfiram 2000mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/10 (10.00%)      1/10 (10.00%)      0/10 (0.00%)    
Hepatobiliary disorders       
Increased aspartate aminotransferase   1/10 (10.00%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Steven G. Deeks
Organization: University of California, San Francisco
Phone: 4156064082 ext 404
EMail: Steven.Deeks@ucsf.edu
Layout table for additonal information
Responsible Party: Steven Deeks, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01944371    
Other Study ID Numbers: 13-10948
DAIDS-ES ID 11864 ( Other Grant/Funding Number: NIAID )
K24AI069994 ( U.S. NIH Grant/Contract )
First Submitted: September 12, 2013
First Posted: September 17, 2013
Results First Submitted: December 8, 2018
Results First Posted: May 5, 2020
Last Update Posted: May 5, 2020