Hemp Evolution

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Results

Viral Load Change by Arm

Change

Marijuana
n=20
n (%)

Dronabinol
n=22
n (%)

Placebo
n=20
n (%)

Increase

greater than 1 log

less than 1 log

no change

5 (25)

10 (50)

2 (10

11 (52)

1 (5)

5 (25)

11 (55)

Decrease

less than 1 log

greater than or equal to 1 log

3 (15)

2 (10)

7 (32)

2 (10)

3 (15)

Mean Change in Log ₁₀ Viral Load by Arm Repeated Measures Model (N=62)
Arm	n	Mean Change	(95% C.I.)
Marijuana	20	-0.15 log	(-0.45, 0.15)
Dronabinol	22	-0.19 log	(-0.48, 0.11)
Placebo	20	+0.06 log	(-0.15, 0.27)

Change in Mean Log ^{10 Viral Load by Arm Illustration of Model (N=62)}

Repeated measures model adjusted for protease inhibitor, baseline viral load & baseline CD4

Caloric Intake & Weight Gain (N=62)
Arm	Calories/Day		Weight (kg)
Arm	Mean	(95% C.I.)	Change	(95% C.I.)
Marijuana	4771	(4630, 4911)	+3.51	(2.17, 4.86)
Dronabinol	4124	(4017, 4230)	+3.18	(2.24, 4.11)
Placebo	3619	(3545, 3692)	+1.30	(0.57, 2.03)

Success of Blinding in Oral Arm (N=42)
	n
Dronabinol Recipients
Thought Dronabinol	17
Thought Placebo	4
Uncertain/changed	1
Placebo Recipients
Thought Placebo	9
Thought Dronabinol	9
Uncertain/changed	2
Correlation - 26/42 (62%)

Adverse Events

Marijuana Arm

Grade 2- Neuropsychiatric Symptoms. Patient chose to leave study.
Grade 2- Tachycardia. Patient remained on study drug
Grade 3- Neuropsychiatric Symptoms. Patient treated with Ativan; remained on study drug

Dronabinol Arm

Grade 2- Neuropsychiatric Symptoms. Patient chose to leave study
Grade 2- Headache & Nausea. Patient chose to leave study
Grade 3- Left Flank Pain, possibly related to Creixivan, not related to study drug. Patient chose to remain on study.
Grade 5- Death occured 58 days after completing study; judged unrelated to study drug (cause of death GI bleed secondary to portal hypertension.)

Placebo Arm

No adverse effects reported

Summary

Cannabinoids, smoked and oral, do not adversely affect HIV RNA levels after 21 days exposure.
Smoked marijuana and dronabinol lead to significant increases in calorific intake and weight.
Future trials should investigate the effectiveness of marijuana in:
- Appetite stimulation/ Weight gain
- Nausea
- Pain

Collaborators

Virology- Tarek Elbeik
Pharmacology- Fran Aweeka, Neil Benowitz
Endocrine/ Metabolic- Kathleen Mulligan, Morris Shambelan, Doris Dare
Immunology- Barry Bredt, Mike McCune
Biostatistics- Joan Hilton, Stanley Shade
Community Consortium- Carroll Child, Roz Leiser, Tom Mitchell, Tiffany Sommer
Clinical Assessments- Judith Aberg, Steven Deeks

Supported by National Institue of Health grant RO1 DA/MH11607. Dronabinol and placebo provided by Roxane Laboratories.

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