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Study to Determine the Pharmacokinetic Behavior of Antiretroviral Drugs in Patients Infected by HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00307502
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : December 4, 2019
Fundacio Lluita Contra la SIDA
Information provided by (Responsible Party):
Germans Trias i Pujol Hospital

Brief Summary:
The purpose of this study is to characterise the pharmacokinetic profiles of non-nucleoside analog reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs), and the influence of the individual characteristics on the pharmacokinetic parameters in the Spanish population of HIV-infected subjects.

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: NVP
Drug: Nevirapine
tablets 200 mg, 400 mg/day
Other Name: Viramune

Experimental: EFV
Drug: Efavirenz
tablets 600 mg, 600 mg/day
Other Name: Sustiva

Experimental: INV
Drug: Indinavir/ritonavir

Indinavir: capsules 400 mg, 1600 mg/day

Ritonavir: capsules 100 mg, 200 mg/day

Other Name: Crixivan/norvir

Experimental: NFV
Drug: Nelfinavir
tablets 250 mg, 2500 mg/day
Other Name: Viracept

Experimental: SQV
Drug: Saquinavir/ritonavir

Saquinavir: tablets 500 mg, 2000 mg/day

Ritonavir: tablets 100 mg, 200 mg/day

Other Name: Invirase/Norvir

Experimental: LPV
Drug: Lopinavir/ritonavir
tablets lopinavir 200 mg + ritonavir 50 mg, 800/200 mg/day
Other Name: Kaletra

Experimental: ATV
Drug: Atazanavir
capsules 200 mg, 400 mg/day
Other Name: Reyataz

Experimental: ATV/rtv
Drug: Atazanavir/ritonavir

Atazanavir: capsules 150 mg, 300 mg/day

Ritonavir: capsules 100 mg, 200 mg/day

Other Name: Reyataz/Norvir

Experimental: Fos-APV
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
Drug: Tipranavir/ ritonavir

Tipranavir: tablets 250 mg, 1000 mg/day

Ritonavir: capsules 100 mg, 400 mg/day

Other Name: Aptivus/Norvir

Experimental: DRV
Drug: Darunavir/ritonavir

Darunavir: tablets 300 mg, 1200 mg/day

Ritonavir: capsules 100 mg, 200 mg/day

Other Name: Prezista/norvir

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Demographic: race, gender, age [ Time Frame: In the 12 h pharmacokinetic curve ]
  2. Clinical: weight, height, liver/renal impairment, HIV infection stage, tobacco/alcohol consumption [ Time Frame: In the 12 h pharmacokinetic curve ]
  3. Adverse events [ Time Frame: In the 12 h pharmacokinetic curve ]
  4. 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 ]
  5. Antiretroviral and concomitant treatment, adherence (number of doses omitted in the last two weeks) [ Time Frame: In the 12 h pharmacokinetic curve ]
  6. 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 ]
  7. Genetic study of polymorphism of CYP3A4 and P-glycoprotein [ Time Frame: In the 12 h pharmacokinetic curve ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age higher than 18 years.
  2. Documented HIV infection (at least one positive Western-blot)
  3. Stable antiretroviral treatment with PI or NNRTI, no changes over the last 4 weeks.
  4. 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:

  1. 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).
  2. Treatment with other drugs with known significant pharmacological interactions with the investigational drug over the previous two weeks.
  3. Unsuitable adherence to treatment (one or more doses omitted in the last week, or two or more doses omitted in the last two weeks).
  4. Presence of clinical findings or a background of gastrointestinal disease or digestive surgery that may interfere in the pharmacokinetics of the medication.
  5. Active consumption of alcohol (>50 grams/day) or illegal drugs (except cannabis).
  6. In the case of women, pregnancy or breastfeeding.
  7. Record or suspicion of inability to cooperate properly

Information from the National Library of Medicine

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 identifier (NCT number): NCT00307502

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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
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Fundacio Lluita Contra la SIDA
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Principal Investigator: Bonaventura Clotet, MD, PhD Lluita contra la Sida Foundation-HIV Unit
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Germans Trias i Pujol Hospital Identifier: NCT00307502    
Other Study ID Numbers: PK-TRANSVERSAL
First Posted: March 28, 2006    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Keywords provided by Germans Trias i Pujol Hospital:
protease inhibitors
non-nucleoside analog reverse transcriptase inhibitors
pharmacokinetic models
treatment experienced
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Atazanavir Sulfate
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors