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My Doctor who is a reknowned HIV specialist and researcher conducted a study and found this result.I was part of that study.

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At 07:24 PM 12/31/2005, ML wrote:

> My Doctor who is a reknowned HIV specialist and researcher conducted a

> study and found this result.

>I was part of that study.

The only published studies of PIs + milk thistle I am aware of are the ones

below. Note the concluding lines. Who is your doctor and what was the study?

M

**

DiCenzo R, Shelton M, Jordan K, Koval C, Forrest A, Reichman R, Morse G.

Coadministration of milk thistle and indinavir in healthy subjects.

Pharmacotherapy. 2003 Jul;23(7):866-70.

University of Buffalo School of Pharmacy and Pharmaceutical Sciences,

Buffalo, New York, USA.

STUDY OBJECTIVE: To determine if milk thistle (silymarin) alters the

pharmacokinetics of indinavir. DESIGN: Sequential crossover trial. SETTING:

General clinical research center. SUBJECTS: Ten healthy subjects.

INTERVENTION: Indinavir 800 mg 3 times/day was given for four doses on days

1 and 2. Silymarin 160 mg 3 times/day was given on days 3-15. On day 16 and

for one dose on day 17, both drugs were given at the same dosages.

MEASUREMENTS AND MAIN RESULTS: Indinavir's pharmacokinetic parameters were

evaluated at steady state both before and after administration of 14 days

of silymarin. Blood samples were collected -0.25, 0.5, 1, 2, 3, 4, and 5

hours after indinavir dosing and assayed by high-performance liquid

chromatography. The final pharmacokinetic model had first-order absorption

after a lag time, and two compartments with first-order elimination from

the central compartment. When given alone and combined with silymarin,

respectively, the geometric mean (95% confidence interval [CI])

steady-state indinavir area under the plasma concentration-time curve was

20.7 hr x mg/L (15.3-28.2 hr x mg/L) and 19.4 hr x mg/L (15.8-23.6 hr x

mg/L) and the trough plasma concentration was 0.340 mg/L (0.232-0.497 mg/L)

and 0.232 mg/L (0.129-0.419 mg/L). CONCLUSION: Silymarin has no apparent

effect on indinavir plasma concentrations.

***

DiCenzo R, Shelton M, Jordan K, Koval C, Forrest A, Reichman R, Morse G.

Coadministration of milk thistle and indinavir in healthy subjects.

Pharmacotherapy. 2003 Jul;23(7):866-70.

University of Buffalo School of Pharmacy and Pharmaceutical Sciences,

Buffalo, New York, USA.

STUDY OBJECTIVE: To determine if milk thistle (silymarin) alters the

pharmacokinetics of indinavir. DESIGN: Sequential crossover trial. SETTING:

General clinical research center. SUBJECTS: Ten healthy subjects.

INTERVENTION: Indinavir 800 mg 3 times/day was given for four doses on days

1 and 2. Silymarin 160 mg 3 times/day was given on days 3-15. On day 16 and

for one dose on day 17, both drugs were given at the same dosages.

MEASUREMENTS AND MAIN RESULTS: Indinavir's pharmacokinetic parameters were

evaluated at steady state both before and after administration of 14 days

of silymarin. Blood samples were collected -0.25, 0.5, 1, 2, 3, 4, and 5

hours after indinavir dosing and assayed by high-performance liquid

chromatography. The final pharmacokinetic model had first-order absorption

after a lag time, and two compartments with first-order elimination from

the central compartment. When given alone and combined with silymarin,

respectively, the geometric mean (95% confidence interval [CI])

steady-state indinavir area under the plasma concentration-time curve was

20.7 hr x mg/L (15.3-28.2 hr x mg/L) and 19.4 hr x mg/L (15.8-23.6 hr x

mg/L) and the trough plasma concentration was 0.340 mg/L (0.232-0.497 mg/L)

and 0.232 mg/L (0.129-0.419 mg/L). CONCLUSION: Silymarin has no apparent

effect on indinavir plasma concentrations.

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If this has been published, please help us out with the reference. I

can't find ANY published reference to interactions between milk

thistle and HIV antivirals.

Who is this " reknowned HIV specialist " ? Where was the study done?

There is a reference to milk thistle INCREASING levels of some

medications . . .

Bob

> My Doctor who is a reknowned HIV specialist and researcher conducted a study

and found this result.

>I was part of that study.

>

>

>

>---------------------------------

>Yahoo! Shopping

> Find Great Deals on Holiday Gifts at Yahoo! Shopping

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I know of a study that was listed on ACRIA involving sylmarin and it's safety in people with HIV/HCV coinfection. It is only a pilot study at Mount Sinai in Manhattan but I haven't heard of any published results. , you'd probably have more info concerning that.

-----Original Message-----From: PozHealth [mailto:PozHealth ]On Behalf Of M. Sent: Sunday, January 01, 2006 2:40 PMTo: pozhealth Subject: Re: MIlk ThistleAt 07:24 PM 12/31/2005, ML wrote:> My Doctor who is a reknowned HIV specialist and researcher conducted a > study and found this result.>I was part of that study.The only published studies of PIs + milk thistle I am aware of are the ones below. Note the concluding lines. Who is your doctor and what was the study? M **DiCenzo R, Shelton M, Jordan K, Koval C, Forrest A, Reichman R, Morse G. Coadministration of milk thistle and indinavir in healthy subjects. Pharmacotherapy. 2003 Jul;23(7):866-70.University of Buffalo School of Pharmacy and Pharmaceutical Sciences, Buffalo, New York, USA.STUDY OBJECTIVE: To determine if milk thistle (silymarin) alters the pharmacokinetics of indinavir. DESIGN: Sequential crossover trial. SETTING: General clinical research center. SUBJECTS: Ten healthy subjects. INTERVENTION: Indinavir 800 mg 3 times/day was given for four doses on days 1 and 2. Silymarin 160 mg 3 times/day was given on days 3-15. On day 16 and for one dose on day 17, both drugs were given at the same dosages. MEASUREMENTS AND MAIN RESULTS: Indinavir's pharmacokinetic parameters were evaluated at steady state both before and after administration of 14 days of silymarin. Blood samples were collected -0.25, 0.5, 1, 2, 3, 4, and 5 hours after indinavir dosing and assayed by high-performance liquid chromatography. The final pharmacokinetic model had first-order absorption after a lag time, and two compartments with first-order elimination from the central compartment. When given alone and combined with silymarin, respectively, the geometric mean (95% confidence interval [CI]) steady-state indinavir area under the plasma concentration-time curve was 20.7 hr x mg/L (15.3-28.2 hr x mg/L) and 19.4 hr x mg/L (15.8-23.6 hr x mg/L) and the trough plasma concentration was 0.340 mg/L (0.232-0.497 mg/L) and 0.232 mg/L (0.129-0.419 mg/L). CONCLUSION: Silymarin has no apparent effect on indinavir plasma concentrations.***DiCenzo R, Shelton M, Jordan K, Koval C, Forrest A, Reichman R, Morse G. Coadministration of milk thistle and indinavir in healthy subjects. Pharmacotherapy. 2003 Jul;23(7):866-70.University of Buffalo School of Pharmacy and Pharmaceutical Sciences, Buffalo, New York, USA.STUDY OBJECTIVE: To determine if milk thistle (silymarin) alters the pharmacokinetics of indinavir. DESIGN: Sequential crossover trial. SETTING: General clinical research center. SUBJECTS: Ten healthy subjects. INTERVENTION: Indinavir 800 mg 3 times/day was given for four doses on days 1 and 2. Silymarin 160 mg 3 times/day was given on days 3-15. On day 16 and for one dose on day 17, both drugs were given at the same dosages. MEASUREMENTS AND MAIN RESULTS: Indinavir's pharmacokinetic parameters were evaluated at steady state both before and after administration of 14 days of silymarin. Blood samples were collected -0.25, 0.5, 1, 2, 3, 4, and 5 hours after indinavir dosing and assayed by high-performance liquid chromatography. The final pharmacokinetic model had first-order absorption after a lag time, and two compartments with first-order elimination from the central compartment. When given alone and combined with silymarin, respectively, the geometric mean (95% confidence interval [CI]) steady-state indinavir area under the plasma concentration-time curve was 20.7 hr x mg/L (15.3-28.2 hr x mg/L) and 19.4 hr x mg/L (15.8-23.6 hr x mg/L) and the trough plasma concentration was 0.340 mg/L (0.232-0.497 mg/L) and 0.232 mg/L (0.129-0.419 mg/L). CONCLUSION: Silymarin has no apparent effect on indinavir plasma concentrations.

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I also questioned the statement that milk thistle interacts with PIs. I don't know of any study finding this. The person who says there is such a study should tell us where to find this study.

Jules

If this has been published, please help us out with the reference. I

can't find ANY published reference to interactions between milk

thistle and HIV antivirals.

Who is this "reknowned HIV specialist"? Where was the study done?

There is a reference to milk thistle INCREASING levels of some

medications . . .

Bob

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Share on other sites

At 09:56 PM 1/1/2006, Texas Veda wrote:

I know of a study that was

listed on ACRIA involving sylmarin and it's safety in people with

HIV/HCV coinfection. It is only a pilot study at Mount Sinai in Manhattan

but I haven't heard of any published results. , you'd probably have

more info concerning that.

As a matter of fact, yes. This is the one clinical trial success FIAR has

had since it started. We collaborated with Mount Sinai to develop the

study and it is still enrolling. It is a 52-week, randomized,

double-blind, placebo-controlled study to evaluate the safety and

preliminary efficacy of milk thistle in the setting of HIV-Hep C

coinfection.

Enrollment has been excruciatingly slow. I'm not sure when the results

will be ready but perhaps later this year we will have some preliminary

results. We're also looking at platelets and other liver markers as

measures of any potential effect on these surrogate liver fibrosis

markers that are gaining interest as an alternative to biopsy.

M.

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