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Short-Term Effects of Cannabinoids
on HIV Viral Load
Donald
I. Abrams, Roslyn J. Leiser, Stanley B. Shade, Joan Hilton, Tarek Elbeik,
and the THC Study Team, University of California, San Francisco
| Introduction |
- Widespread use
of smoked marijuana in patients with symptomatic HIV infection in
San Francisco prompted this safety study.
- Cannabinoid use
could potentially alter HIV RNA levels by:
- immune modulation
via the CB2, or
- cannabinoid:
protease inhibitor (PI) interactions via cytochrome p450.
- The objective
of this study is to determine the safety/toxicity profile of cannabinoids
in persons with HIV disease.
- Does metabolic
interactions between cannabinoids and PI or cannabinoids and the
immune system alter HIV RNA after 21 days' exposure.
- Is their
a different metabolic interaction between PIs and cannabinoids
whether orally or inhaled
- What are
the short term cannabinoid effects on endocrine function, appetite,
energy intake and expenditure, body weight and composition.
|
| Methods |
- Random, partially
blinded, placebo controlled 21-day inpatient study.
- General Clinical
Research Center admission consisted of 4 lead-in days and 21 study
treatment days.
- First patient
enrolled on May 12, 1999, last completed on May 28, 2000.
- Sixty-seven (67)
patients were randomized to smoke marijuana (3.95% THC), take oral
dronabinol, or take an oral placebo 3 times daily before meals.
- Sixty-two (62)
patients completed the 21 day study period.
- HIV RNA levels
measured using bDNA version 3.0 ten times during the study.
Inclusion
Criteria
- HIV-positive
- Stable anti-retroviral
regimen containing indiravir or nelfinavir.
- Stable HIV RNA
viral load
- Prior use (greater
than or equal to 6 times) of marijuana
Exclusion
Criteria
- Use of marijuana
within 30 days of enrollment
- Active substance
abuse including tobacco
- Wasting (greater
than 10% weight loss in the past six months)
- Active opportunistic
infections or malignancies requiring acute treatment
|
| Patient
Characteristics |
| |
Clinical Characteristics
(N=67) |
| Gender |
|
|
| Male |
60 |
90 |
| Female |
3 |
4 |
| Male
or Female Transgender |
4 |
6 |
| Age |
n |
% |
| less
than 40 |
22 |
33 |
| 40-49 |
33 |
49 |
| 50+ |
12 |
18 |
| Median:
43 Range: 26-80 |
|
|
| Ethnicity |
n |
% |
| White |
22 |
48 |
| African-American/Black |
13 |
19 |
| Latino |
11 |
16 |
| Asian/Pacific
Islander |
2 |
3 |
| Mixed/Other |
9 |
13 |
|
| Characteristics |
n |
% |
| Prior
Opportunistic Infections |
|
|
| Yes |
33 |
49 |
| No |
34 |
51 |
| Baseline
CD4 Count (2 missing) |
n |
% |
| less
than 200 |
18 |
28 |
| 200-499 |
34 |
52 |
| greater
than or equal to 500 |
13 |
20 |
| median
300 range 9-844 |
|
|
| Baseline
Viral Load (copies/ml) |
n |
% |
| less
than 50 |
37 |
55 |
| 50-499 |
10 |
16 |
| 500-9999 |
13 |
19 |
| greater
than 10,000 |
7 |
10 |
| median
less than 50 |
range:
less than 13-34,305 |
|
| Baseline
Weight (kg) |
n |
% |
| less
than 70 |
14 |
23 |
| 70-79 |
19 |
31 |
| 80-89 |
14 |
23 |
| greater
than or equal to 90 |
15 |
24 |
| Median:
79 Range: 44-153 |
|
|
|
|
| Randomization
by Protease Inhibitor and Study Arm (n=67) |
| Protease
Inhibitor |
Marijuana
N (%) |
Dronabinaol
N (%) |
Placebo
N(%) |
Total
n(%) |
| Indinavir |
9 (13) |
12 (18) |
9 (13) |
30 (45) |
| Nelfinavir |
12 (18) |
13 (19) |
12 (18) |
37 (55) |
| Total |
21 (31) |
25 (37) |
21 (31) |
67 |
| There were no statistical
significant differences in patient demographic or clinical characteristics
by study arm |
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