Study to Determine the Pharmacokinetic Behavior of Antiretroviral Drugs in Patients Infected by HIV
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ClinicalTrials.gov Identifier: NCT00307502 |
Recruitment Status
:
Completed
First Posted
: March 28, 2006
Last Update Posted
: February 23, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Nevirapine Drug: Efavirenz Drug: Indinavir/ritonavir Drug: Nelfinavir Drug: Saquinavir/ritonavir Drug: Lopinavir/ritonavir Drug: Atazanavir Drug: Atazanavir/ritonavir Drug: Fos-amprenavir/ritonavir Drug: Tipranavir/ ritonavir Drug: Darunavir/ritonavir | Phase 1 |
The antiretrovirals were administered conventionally according to fixed dosage systems, or depending on the weight of the individual in the case of certain agents. However, the plasma levels of antiretrovirals following the administration of a fixed dose present a marked interindividual variability. Moreover, a significant proportion of the patients on treatment with PIs presented plasma levels regarded as suboptimal in previous studies.
Moreover, for the correct modification of the dosage of a drug, populational data on its pharmacokinetic behaviour during the dosing interval is required. Only by integrating this information with the specific characteristics of each individual is it possible, using mathematical models, to estimate the effect that a modification of the dosage of the drug would have on its plasma concentration. However, populational data on the pharmacokinetic behaviour of antiretroviral agents are still very limited at this moment, and have not always been obtained in populations similar to the one to which they are to be applied.
Thus, knowing the pharmacokinetic behaviour of the antiretroviral agents in our population and the influence of certain individual characteristics on this behaviour may be of great interest, since only in this way will we be able to tailor the dosage of antiretrovirals reliably in our patients.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 675 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Cross-sectional Study for the Characterisation of the Pharmacokinetic Parameters of Protease Inhibitors and Non-nucleoside Analog Reverse Transcriptase Inhibitors in the Spanish Population of HIV-infected Subjects |
Study Start Date : | January 2005 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: NVP
Nevirapine
|
Drug: Nevirapine
tablets 200 mg, 400 mg/day
Other Name: Viramune
|
Experimental: EFV
Efavirenz
|
Drug: Efavirenz
tablets 600 mg, 600 mg/day
Other Name: Sustiva
|
Experimental: INV
Indinavir/ritonavir
|
Drug: Indinavir/ritonavir
Indinavir: capsules 400 mg, 1600 mg/day Ritonavir: capsules 100 mg, 200 mg/day Other Name: Crixivan/norvir
|
Experimental: NFV
Nelfinavir
|
Drug: Nelfinavir
tablets 250 mg, 2500 mg/day
Other Name: Viracept
|
Experimental: SQV
Saquinavir/ritonavir
|
Drug: Saquinavir/ritonavir
Saquinavir: tablets 500 mg, 2000 mg/day Ritonavir: tablets 100 mg, 200 mg/day Other Name: Invirase/Norvir
|
Experimental: LPV
Lopinavir/ritonavir
|
Drug: Lopinavir/ritonavir
tablets lopinavir 200 mg + ritonavir 50 mg, 800/200 mg/day
Other Name: Kaletra
|
Experimental: ATV
Atazanavir
|
Drug: Atazanavir
capsules 200 mg, 400 mg/day
Other Name: Reyataz
|
Experimental: ATV/rtv
Atazanavir/ritonavir
|
Drug: Atazanavir/ritonavir
Atazanavir: capsules 150 mg, 300 mg/day Ritonavir: capsules 100 mg, 200 mg/day Other Name: Reyataz/Norvir
|
Experimental: Fos-APV
Fos-amprenavir/ritonavir
|
Drug: Fos-amprenavir/ritonavir
Fos-amprenavir: capsules 700 mg, 1400 mg/day Ritonavir: capsules 100 mg, 200 mg/day Other Name: Telzir/norvir
|
Experimental: TPV
Tipranavir/ritonavir
|
Drug: Tipranavir/ ritonavir
Tipranavir: tablets 250 mg, 1000 mg/day Ritonavir: capsules 100 mg, 400 mg/day Other Name: Aptivus/Norvir
|
Experimental: DRV
Darunavir/ritonavir
|
Drug: Darunavir/ritonavir
Darunavir: tablets 300 mg, 1200 mg/day Ritonavir: capsules 100 mg, 200 mg/day Other Name: Prezista/norvir
|
- The primary endpoint is the plasma concentration of the PI/NNRTI drugs (Ka absorption constant, CI: plasma clearance, Vd: volume of distribution). [ Time Frame: In the 12 hour (h) pharmacokinetic curve ]
- Demographic: race, gender, age [ Time Frame: In the 12 h pharmacokinetic curve ]
- Clinical: weight, height, liver/renal impairment, HIV infection stage, tobacco/alcohol consumption [ Time Frame: In the 12 h pharmacokinetic curve ]
- Adverse events [ Time Frame: In the 12 h pharmacokinetic curve ]
- Laboratory: creatinine, albumin, Quick Index, bilirubin, GOT, GPT, GGT, FA, CD4 lymphocyte count, HIV viral load, HBsAg and anti-HCV, alpha acid glycoprotein [ Time Frame: In the 12 h pharmacokinetic curve ]
- Antiretroviral and concomitant treatment, adherence (number of doses omitted in the last two weeks) [ Time Frame: In the 12 h pharmacokinetic curve ]
- Pharmacokinetics: maximum concentration (Cmax), time to maximum concentration (Tmax), plasma concentration at the end of the posology interval (Ctrough), half-life (T1/2), area under the curve (ABC) [ Time Frame: In the 12 h pharmacokinetic curve ]
- Genetic study of polymorphism of CYP3A4 and P-glycoprotein [ Time Frame: In the 12 h pharmacokinetic curve ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age higher than 18 years.
- Documented HIV infection (at least one positive Western-blot)
- Stable antiretroviral treatment with PI or NNRTI, no changes over the last 4 weeks.
- Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or negative pregnancy test.
Exclusion Criteria:
- Subjects on treatment with more than one PI or with combinations of PI and NNRTI (the use of ritonavir in doses below 400 mg BID will not be regarded as a second PI).
- Treatment with other drugs with known significant pharmacological interactions with the investigational drug over the previous two weeks.
- Unsuitable adherence to treatment (one or more doses omitted in the last week, or two or more doses omitted in the last two weeks).
- Presence of clinical findings or a background of gastrointestinal disease or digestive surgery that may interfere in the pharmacokinetics of the medication.
- Active consumption of alcohol (>50 grams/day) or illegal drugs (except cannabis).
- In the case of women, pregnancy or breastfeeding.
- Record or suspicion of inability to cooperate properly

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307502
Spain | |
Germans Trias i Pujol Hospital | |
Badalona, Barcelona, Spain, 08916 | |
Hospital de Figueres | |
Figueras, Barcelona, Spain, 17600 | |
Fundació Hospital-Asil de Granollers | |
Granollers, Barcelona, Spain, 08400 | |
Hospital de Vic | |
Vic, Barcelona, Spain, 08500 | |
Hospital Universitari Sant Joan de Reus | |
Reus, Tarragona, Spain, 43201 | |
Hospital de la Santa Creu i Sant Pau | |
Barcelona, Spain, 08025 |
Principal Investigator: | Bonaventura Clotet, MD, PhD | Lluita contra la Sida Foundation-HIV Unit |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Lluita Sida Foundation |
ClinicalTrials.gov Identifier: | NCT00307502 History of Changes |
Other Study ID Numbers: |
PK-TRANSVERSAL 2004-001516-32 |
First Posted: | March 28, 2006 Key Record Dates |
Last Update Posted: | February 23, 2010 |
Last Verified: | February 2010 |
Keywords provided by Germans Trias i Pujol Hospital:
protease inhibitors non-nucleoside analog reverse transcriptase inhibitors pharmacokinetic models treatment experienced HIV |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Darunavir Atazanavir Sulfate HIV Protease Inhibitors Nelfinavir |
Indinavir Saquinavir Amprenavir Fosamprenavir Nevirapine Tipranavir Efavirenz Protease Inhibitors Reverse Transcriptase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |