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In the first study to be approved by the labyrinthine U.S. Federal cannabinoid research bureaucracy in years, smoked Cannabis was found to be the most effective treatment of those treatments compared for HIV/AIDS, without causing negative drug-drug interactions.

Doctor Donald Abrams and his research team from the University of California at San Francisco compared the effects of Cannabis (smoked), Marinol (dronabinol) and a placebo on a population of HIV positive patients. He announced his preliminary results at the XIII International AIDS Conference in Durban, South Africa in July of 2000. There was little media coverage of this remarkable presentation. In his comments, Doctor Abrams described significant clinical improvement in health—measured weight gain—without increasing the viral load of the Human Immunodeficiency Virus (HIV) among participants who smoked Cannabis.

The "viral load"

One basic interpretation of HIV status is the measurement of a person's "viral load". The viral load is measured as a blood test that registers HIV RNA. 3

A result of fewer than 50 copies per milliliter (copies/ml.) of blood is considered "undetectable" or not significant enough to cause disease. Increasing viral load is an indication that the virus that causes AIDS is replicating.

Many HIV patients endure complicated and difficult regimes of drugs called antiretrovirals. Protease inhibitors are one type of antiretroviral drug. This class of drugs ideally interferes with the reproduction of the HIV and keeps the level of the virus low enough to not allow opportunistic infections to develop. Unfortunately, protease inhibitors have all kinds of serious side effects. Many patients report serious nausea, headache, anorexia, diarrhea and liver function abnormalities.

The UCSF research team used repeated measurement of viral load over the length of the study to determine the effect different cannab-inoid-based therapies. The study evaluated the effect of Cannabis smoking, Marinol (dronabinol) and a placebo.

The study

The research protocol consisted of 67 initial subjects. (Sixty-two completed the study.) All the subjects were undergoing antiretroviral therapy with either of two common protease inhibitors, indinivir (30 subjects), or nelfinavir (37 subjects). Baseline measurements of viral load were taken twice on all subjects. At the beginning of the study over half the participants, thirty-seven, had viral loads less than 50 copies/ml. Ten persons had HIV RNA levels of 50-499 copies/ml., thirteen had levels of 500-9999 copies/ml., and seven persons had levels over 10,000 copies/ml.

All 67 participants were randomly divided into three groups. The first group consisting of 21 patients used smoked U.S. Government-grown Cannabis with a THC percentage of around 4%. (Four percent THC is considered medium quality). The second group of 25 patients was treated with Marinol (dronabinol). The third group of 21 received an oral placebo. 4

Blood measurements of viral load were taken eight times over the twenty-one day study. In the beginning weeks, viral load was measured every three to four days. Measurements were increased in frequency as the weeks progressed so that by the third week, viral load was measured every other day. The dosage of each drug was as follows: Cannabis smoking patients smoked one cigarette three times a day before meals. The dronabinol and placebo groups each received a 2.5-milligram capsule, or placebo, also three times per day before meals.

During the length of the study, five subjects left for various reasons. One subject left the smoked Cannabis section because of what were called "neuropsychiatric" symptoms. Two left the dronabinol section, one for "neuropsychiatric" effects and one for headache and nausea. Other minor side effects occurred including rapid heart rate.

The results

After the three-week study concluded, a statistical analysis was conducted comparing the baseline measurements of weight and HIV RNA, with those obtained at various intervals. This analysis showed that the 36 participants with undetectable viral loads (under 50 copies/ml) at the beginning of the study remained in the same category. This held true for the dronabinol, Cannabis and placebo users. The 26 participants who had measurable viral loads at the beginning of the study showed declines over time. The dronabinol/Cannabis groups showed greater declines in viral load than did the placebo group although this was statistically insignificant according to the researchers. What was of major importance was the conclusion that smoking Cannabis did not appear to interfere with the efficacy of protease inhibitor therapy or cause the HIV to increase. In other words, smoking Cannabis did not seem to lead to immunological compromise in this key indicator of HIV status. A more complex immunological analysis had not been done at the time of the Durban AIDS Conference. Future analysis may support or refute the conclusion that Cannabis does not interfere with more complicated immunological functions.

But there was another surprising and significant result of this study, something that HIV/AIDS patients have long since known: Cannabis stimulates appetite. This correlation was established because of the measurements of weight taken before and during the study that demonstrated significant weight gain among both the dronabinol and smoked Cannabis groups. Since Marinol is presently clinically indicated for appetite stimulation in HIV and cancer, this was not surprising. Of more importance was the comparison of weight gain between the Cannabis and Dronabinol groups. The Cannabis-smoking group

Blood measurements of viral load were taken eight times over the twenty-one day study.

The dronabinol/ Cannabis groups showed greater declines in viral load than did the placebo group .smoking Cannabis did not appear to interfere with the efficacy of protease inhibitor therapy or cause the HIV to increase.

Clearly, the Cannabis-smoking group demonstrated the greatest improvement in health as measured by weight gain.

in these circumstances .smoked Cannabis was the most beneficial treatment of all studied.

gained an average of 3.5 kilograms (7.7 lbs.), more than any other group. The placebo group gained 1.3 kilograms (2.8 lbs.) and the dronabinol group gained 3.1 kilograms (6.8 lbs.). Clearly, the Cannabis-smoking group demonstrated the greatest improvement in health as measured by weight gain.

None of these results can conclusively establish that Cannabis is without serious adverse interactions in some people. Thus, the results will not settle this question and other researchers will look for more subtle interactions between Cannabis and HIV/AIDS. There could well be some other unknown factor that would make Cannabis use not desirable for people suffering from HIV. More extensive measurement of these results will shed some deeper understanding on how cannab-inoids interact with protease inhibitors and immune function. But the study clearly demonstrated, in these circumstances at least, that smoked Cannabis was the most beneficial treatment of all studied- even using relatively poor quality government Cannabis. Whether these results, paid for by federal tax dollars, will lead to meaningful federal movement on the medical Cannabis issue is much more doubtful.

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