Pharmacokinetic Interactions Between Buprenorphine and Tipranavir/Ritonavir (BUTI)
|ClinicalTrials.gov Identifier: NCT00486330|
Recruitment Status : Completed
First Posted : June 14, 2007
Results First Posted : November 21, 2012
Last Update Posted : November 21, 2012
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Buprenorphine, Tipranavir and ritonavir||Not Applicable|
A large number of people with HIV-infection obtained HIV through injection drug use. Some of these people are currently being treated with buprenorphine/naloxone (BUP) for their addiction and with medications for HIV infection. Tipranavir is a medication that was recently approved by the Food and Drug Administration (FDA) for the treatment of HIV-infection. Tipranavir is given in combination with another HIV medication, ritonavir. Tipranavir acts by making it more difficult for the virus that causes AIDS to multiply and cause more damage to the immune system. Ritonavir acts by increasing the amount of tipranavir available to fight HIV.
Earlier studies looking at the combination of BUP and HIV medications have shown that BUP and some HIV medications act differently when taken together. It is important to learn if taking BUP and HIV medications together results in changes in the blood level of either medication. If the HIV medication decreases the level of BUP in the blood, an individual taking BUP and HIV medications may experience symptoms of withdrawal ("dope sickness"), even while taking their usual dose of BUP. On the other hand, if BUP decreases the amount of HIV medication in the blood, then the HIV medication may be less effective in controlling HIV infection. It is therefore important to learn if tipranavir/ritonavir and BUP will affect each other when taken together.
In order to learn about the effects of BUP on tipranavir/ritonavir, we will need to measure the amount of BUP in your blood for 24 hours after you have taken tipranavir/ritonavir and BUP together and then compare that to the amount of BUP in your blood when you are not taking tipranavir/ritonavir.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Pharmacokinetic Interactions Between Buprenorphine/Naloxone and Tipranavir/Ritonavir in HIV-Negative Subjects Chronically Receiving Buprenorphine/Naloxone|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
|Buprenorphine plus Tipranavir/Ritonavir||
Drug: Buprenorphine, Tipranavir and ritonavir
After determining buprenorphine/naloxone pharmacokinetics over a 24-hour period, tipranavir/ritonavir and buprenorphine/naloxone will be coadministered for 7 days.
- Area Under the Curve of BUP/NLX With TPV/r (h*ng/mL) [ Time Frame: 10 days ]Non-compartmental methods were used for pharmacokinetic analysis. The area under the plasma drug concentration-time curve was estimated by linear-log trapezoidal rule at 24-hrs.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486330
|United States, Connecticut|
|Yale University School of Medicine AIDS Program|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Robert D Bruce, MD||Yale University|