Trial Outcomes & Findings for Effect of Methamphetamine on Residual Latent HIV Disease Study (NCT NCT03825536)
NCT ID: NCT03825536
Last Updated: 2025-08-29
Results Overview
The change in HIV reservoir size (as measured by cell-associated HIV RNA levels) over a 4 hour study period.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
14 participants
Primary outcome timeframe
4 hours
Results posted on
2025-08-29
Participant Flow
Participant milestones
| Measure |
Oral Methamphetamine, Then Placebo Oral Capsule
Participants will be randomized to oral methamphetamine first then placebo oral capsule using a random number generator. When oral methamphetamine is administered, an initial 10 mg of oral methamphetamine study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose two hours later. Then the participant will receive the placebo oral capsule for their second treatment phase starting at approximately Day 77. For the placebo treatment, one placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.
Oral Methamphetamine: An initial 10 mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose (over-encapsulated to look similar to placebo capsule) two hours later.
Placebo oral capsule: One placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.
|
Placebo Oral Capsule, Then Oral Methamphetamine
Participants will be randomized to a placebo oral capsule first, then oral methamphetamine using a random number generator. For the placebo treatment, one placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later. Then the participant will receive the oral methamphetamine capsule for their second treatment phase starting at approximately Day 77. When oral methamphetamine is administered, an initial 10 mg of oral methamphetamine study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose two hours later.
Oral Methamphetamine: An initial 10 mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose (over-encapsulated to look similar to placebo capsule) two hours later.
Placebo oral capsule: One placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.
|
|---|---|---|
|
First Intervention (30 Days)
STARTED
|
7
|
7
|
|
First Intervention (30 Days)
COMPLETED
|
5
|
6
|
|
First Intervention (30 Days)
NOT COMPLETED
|
2
|
1
|
|
Washout (30 Days)
STARTED
|
5
|
6
|
|
Washout (30 Days)
COMPLETED
|
5
|
5
|
|
Washout (30 Days)
NOT COMPLETED
|
0
|
1
|
|
Second Intervention (30 Days)
STARTED
|
5
|
5
|
|
Second Intervention (30 Days)
COMPLETED
|
5
|
5
|
|
Second Intervention (30 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Methamphetamine on Residual Latent HIV Disease Study
Baseline characteristics by cohort
| Measure |
Oral Methamphetamine, Then Placebo Oral Capsule
n=5 Participants
Participants will be randomized to oral methamphetamine first then placebo oral capsule using a random number generator. When oral methamphetamine is administered, an initial 10 mg of oral methamphetamine study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose two hours later. Then the participant will receive the placebo oral capsule for their second treatment phase starting at approximately Day 77. For the placebo treatment, one placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.
Oral Methamphetamine: An initial 10 mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose (over-encapsulated to look similar to placebo capsule) two hours later.
Placebo oral capsule: One placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.
|
Placebo Oral Capsule, Then Oral Methamphetamine
n=5 Participants
Participants will be randomized to a placebo oral capsule first, then oral methamphetamine using a random number generator. For the placebo treatment, one placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later. Then the participant will receive the oral methamphetamine capsule for their second treatment phase starting at approximately Day 77. When oral methamphetamine is administered, an initial 10 mg of oral methamphetamine study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose two hours later.
Oral Methamphetamine: An initial 10 mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose (over-encapsulated to look similar to placebo capsule) two hours later.
Placebo oral capsule: One placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 9.50 • n=5 Participants
|
44.4 years
STANDARD_DEVIATION 9.34 • n=7 Participants
|
45 years
STANDARD_DEVIATION 8.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 hoursThe change in HIV reservoir size (as measured by cell-associated HIV RNA levels) over a 4 hour study period.
Outcome measures
| Measure |
Oral Methamphetamine, Then Placebo Oral Capsule
n=5 Participants
Participants will be randomized to oral methamphetamine first then placebo oral capsule using a random number generator. When oral methamphetamine is administered, an initial 10 mg of oral methamphetamine study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose two hours later. Then the participant will receive the placebo oral capsule for their second treatment phase starting at approximately Day 77. For the placebo treatment, one placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.
Oral Methamphetamine: An initial 10 mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose (over-encapsulated to look similar to placebo capsule) two hours later.
Placebo oral capsule: One placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.
|
Placebo Oral Capsule, Then Oral Methamphetamine
n=5 Participants
Participants will be randomized to a placebo oral capsule first, then oral methamphetamine using a random number generator. For the placebo treatment, one placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later. Then the participant will receive the oral methamphetamine capsule for their second treatment phase starting at approximately Day 77. When oral methamphetamine is administered, an initial 10 mg of oral methamphetamine study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose two hours later.
Oral Methamphetamine: An initial 10 mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose (over-encapsulated to look similar to placebo capsule) two hours later.
Placebo oral capsule: One placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.
|
|---|---|---|
|
HIV Transcription (Cell-associated HIV RNA) in Peripheral Blood
|
10.45 copies/million cells
Interval 1.3 to 31.79
|
57.38 copies/million cells
Interval 27.59 to 404.7
|
SECONDARY outcome
Timeframe: 4 hoursThe change in plasma pro-inflammatory IL-1B levels over a 4 hour study period.
Outcome measures
| Measure |
Oral Methamphetamine, Then Placebo Oral Capsule
n=10 Participants
Participants will be randomized to oral methamphetamine first then placebo oral capsule using a random number generator. When oral methamphetamine is administered, an initial 10 mg of oral methamphetamine study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose two hours later. Then the participant will receive the placebo oral capsule for their second treatment phase starting at approximately Day 77. For the placebo treatment, one placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.
Oral Methamphetamine: An initial 10 mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose (over-encapsulated to look similar to placebo capsule) two hours later.
Placebo oral capsule: One placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.
|
Placebo Oral Capsule, Then Oral Methamphetamine
n=10 Participants
Participants will be randomized to a placebo oral capsule first, then oral methamphetamine using a random number generator. For the placebo treatment, one placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later. Then the participant will receive the oral methamphetamine capsule for their second treatment phase starting at approximately Day 77. When oral methamphetamine is administered, an initial 10 mg of oral methamphetamine study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose two hours later.
Oral Methamphetamine: An initial 10 mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose (over-encapsulated to look similar to placebo capsule) two hours later.
Placebo oral capsule: One placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.
|
|---|---|---|
|
Systemic Inflammation (Plasma Pro-inflammatory Cytokine Levels)
|
0.875 pg/uL
Interval 0.0 to 3.473
|
0.054 pg/uL
Interval -0.032 to 0.56
|
SECONDARY outcome
Timeframe: 4 hoursThe change in host gene expression as measured by RNA-seq over a 4 hour study period
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 hoursThe change in tyramine (TAAR1 signaling metabolite) levels over a 4 hour study period.
Outcome measures
| Measure |
Oral Methamphetamine, Then Placebo Oral Capsule
n=9 Participants
Participants will be randomized to oral methamphetamine first then placebo oral capsule using a random number generator. When oral methamphetamine is administered, an initial 10 mg of oral methamphetamine study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose two hours later. Then the participant will receive the placebo oral capsule for their second treatment phase starting at approximately Day 77. For the placebo treatment, one placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.
Oral Methamphetamine: An initial 10 mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose (over-encapsulated to look similar to placebo capsule) two hours later.
Placebo oral capsule: One placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.
|
Placebo Oral Capsule, Then Oral Methamphetamine
n=9 Participants
Participants will be randomized to a placebo oral capsule first, then oral methamphetamine using a random number generator. For the placebo treatment, one placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later. Then the participant will receive the oral methamphetamine capsule for their second treatment phase starting at approximately Day 77. When oral methamphetamine is administered, an initial 10 mg of oral methamphetamine study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose two hours later.
Oral Methamphetamine: An initial 10 mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose (over-encapsulated to look similar to placebo capsule) two hours later.
Placebo oral capsule: One placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.
|
|---|---|---|
|
Trace Amine Receptor 1 (TAAR1) Signaling Metabolite Levels in in Peripheral Blood
|
-215.901 ug
Interval -296.094 to -132.644
|
-171.506 ug
Interval -340.327 to -92.9
|
Adverse Events
Oral Methamphetamine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Oral Capsule
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oral Methamphetamine
n=14 participants at risk
An initial 10 mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug was administered to assess tolerability, followed by a subsequent 15 mg oral dose (over-encapsulated to look similar to placebo capsule) two hours later.
|
Placebo Oral Capsule
n=14 participants at risk
One placebo oral capsule was administered orally on treatment day, followed by a second oral placebo capsule two hours later.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • Number of events 1 • 4 months
Regular monitoring of vitals (e.g. BP, O2 levels) and ECG by MD present before and after administration of dosages on treatment days.
|
0.00%
0/14 • 4 months
Regular monitoring of vitals (e.g. BP, O2 levels) and ECG by MD present before and after administration of dosages on treatment days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place