Trial Outcomes & Findings for Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine (NCT NCT00308620)
NCT ID: NCT00308620
Last Updated: 2020-06-04
Results Overview
HIV-1 viral load change between baseline and 8 weeks
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
13 participants
Primary outcome timeframe
baseline and 8 weeks
Results posted on
2020-06-04
Participant Flow
2006-2008 recruitment of volunteers in HIV care but electing to not receive ART.
Participant milestones
| Measure |
Chloroquine 500mg
Chloroquine 500mg PO once daily x 8 weeks
|
Placebo
Placebo once daily for 8 weeks
|
Chloroquine 250mg
Chloroquine 250mg PO once daily x 8 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
6
|
|
Overall Study
COMPLETED
|
2
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Chloroquine 500mg
Chloroquine 500mg PO once daily x 8 weeks
|
Placebo
Placebo once daily for 8 weeks
|
Chloroquine 250mg
Chloroquine 250mg PO once daily x 8 weeks
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine
Baseline characteristics by cohort
| Measure |
Chloroquine 500mg
n=3 Participants
Chloroquine 500mg PO once daily x 8 weeks
|
Placebo
n=4 Participants
Placebo once daily for 8 weeks
|
Chloroquine 250mg
n=6 Participants
Chloroquine 250mg PO once daily x 8 weeks
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 15 • n=99 Participants
|
34 years
STANDARD_DEVIATION 5 • n=107 Participants
|
36 years
STANDARD_DEVIATION 5 • n=206 Participants
|
36.5 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
6 participants
n=206 Participants
|
13 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: baseline and 8 weeksHIV-1 viral load change between baseline and 8 weeks
Outcome measures
| Measure |
Chloroquine 250mg or 500mg
n=9 Participants
Chloroquine 250mg or 500mg orally once daily x 8 weeks. n=6 for 250mg; n=3 for 500mg
|
Placebo
n=4 Participants
Placebo orally once daily for 8 weeks
|
|---|---|---|
|
HIV Viral Load Change
|
-.083 log10 copies/mL
Standard Deviation .5
|
0.0 log10 copies/mL
Standard Deviation .1
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Analysis of Chloroquine arms is pooled.
The Change in the percentages of CD38+ HLA-DR+ CD8 and CD4 memory T cells from baseline to 8 weeks.
Outcome measures
| Measure |
Chloroquine 250mg or 500mg
n=7 Participants
Chloroquine 250mg or 500mg orally once daily x 8 weeks. n=6 for 250mg; n=3 for 500mg
|
Placebo
n=3 Participants
Placebo orally once daily for 8 weeks
|
|---|---|---|
|
Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks
CD8 CD38+HLA-DR+
|
-2.5 percentage change
Interval -7.0 to 2.0
|
1.85 percentage change
Interval -3.0 to 2.0
|
|
Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks
CD4 ki67+
|
-2.0 percentage change
Interval -3.0 to 2.0
|
1.4 percentage change
Interval -0.5 to 3.0
|
Adverse Events
Chloroquine 500mg
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Chloroquine 250mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chloroquine 500mg
n=3 participants at risk
Chloroquine 500mg PO once daily x 8 weeks
|
Placebo
n=4 participants at risk
Placebo once daily for 8 weeks
|
Chloroquine 250mg
n=6 participants at risk
Chloroquine 250mg PO once daily x 8 weeks
|
|---|---|---|---|
|
Social circumstances
Death (non-related)
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place