Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Short-term Disulfiram Administration to Accelerate the Decay of the HIV Reservoir in Antiretroviral-treated HIV Infected Individuals

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: NCT01286259
Recruitment Status : Completed
First Posted : January 31, 2011
Results First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition HIV-1 Infection
Intervention Drug: Disulfiram
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Arm
Hide Arm/Group Description Disulfiram: Open label 500mg disulfiram per day by mouth for 14 days
Period Title: Overall Study
Started 16
Completed 16
Not Completed 0
Arm/Group Title Intervention Arm
Hide Arm/Group Description Disulfiram: Open label 500mg disulfiram per day by mouth for 14 days
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants
47.5
(24 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
1
   6.3%
Male
15
  93.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Impact of Two Weeks of Disulfiram, as Measured by the Fold Change in the Infectious Units Per Million Cells (IUPM) Between Baseline and Week 12
Hide Description The size of the latent reservoir from each participant was measured by limiting dilution co-culture assay and reported as "infectious units per million cells" (IUPM).This assay measures the frequency of peripheral blood cells from which replication-competent HIV can be grown. The assay was performed at a baseline visit (two weeks before dosing began) and week 12 (10 weeks after the last dose). The primary outcome was the fold-change in IUPM before and after disufiram.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The size of the latent reservoir from each participant was measured by limiting dilution co-culture assay two weeks before and ten weeks after disulfiram administration..
Arm/Group Title Intervention Arm
Hide Arm/Group Description:
Disulfiram: Open label 500mg disulfiram per day by mouth for 14 days
Overall Number of Participants Analyzed 16
Overall Number of Units Analyzed
Type of Units Analyzed: Blood samples
32
Mean (95% Confidence Interval)
Unit of Measure: Fold change in IUPM
1.16
(0.70 to 1.92)
2.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description The safety and tolerability of a two-week course of disulfiram was defined using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009). Details are available on the RSC website (http://rsc.tech-res.com/safetyandpharmacovigilance/). The number of adverse events and their grade was determined for each subject.
Time Frame Two weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Arm
Hide Arm/Group Description:
Disulfiram: Open label 500mg disulfiram per day by mouth for 14 days
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Primary Outcome
Title The Fold Change in Mean Levels of Viremia During and After Disulfiram Dosing as Compared to Baseline Levels
Hide Description Residual viremia was measured using a singe copy assay (SCA) in plasma samples obtained at enrollment, Days -14, -7, 0, 2, 4, 7, 9, 11, 14, 16, and 18, and at weeks 3, 4, 8 and 12. The level of residual viremia measured by SCA prior to disulfiram (Days 14, 17 and 0), during treatment (Days 1 to 14) and after dosing (Days 16 and 18) was modelled using negative binomial regression, and reported as the mean fold-change during and after disulfiram as compared to that during the baseline period.
Time Frame Baseline to Day 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Arm
Hide Arm/Group Description:
Disulfiram: Open label 500mg disulfiram per day by mouth for 14 days
Overall Number of Participants Analyzed 16
Mean (95% Confidence Interval)
Unit of Measure: Fold change
1.5
(0.9 to 2.7)
4.Primary Outcome
Title Number of Participants With Detectable Plasma HIV RNA
Hide Description Plasma HIV RNA levels were measured weekly using a commercial assay. The number of participants who had a detectable viral load (> 50 copies RNA/mL) was determined.
Time Frame Two weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Arm
Hide Arm/Group Description:
Disulfiram: Open label 500mg disulfiram per day by mouth for 14 days
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
1
   6.3%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Arm
Hide Arm/Group Description Disulfiram: Open label 500mg disulfiram per day by mouth for 14 days
All-Cause Mortality
Intervention Arm
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Intervention Arm
Affected / at Risk (%)
Total   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Arm
Affected / at Risk (%)
Total   0/16 (0.00%) 
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: (415) 476-4082
EMail: Steven.Deeks@ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01286259    
Other Study ID Numbers: IRB 10-02648
First Submitted: January 27, 2011
First Posted: January 31, 2011
Results First Submitted: November 6, 2018
Results First Posted: June 30, 2020
Last Update Posted: June 30, 2020