Pilot Study to Compare the Pharmacokinetics Parameters in Plasma and Intracellular of Raltegravir Administered Once a Day in Adult Patients Infected With HIV
1 other identifier
interventional
5
1 country
2
Brief Summary
The purpose of this study is to compare plasma and intracellular pharmacokinetic parameters of raltegravir 800 mg administered once daily in HIV infected patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 hiv-infections
Started Nov 2009
Shorter than P25 for phase_4 hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2009
CompletedFirst Posted
Study publicly available on registry
October 15, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedDecember 5, 2019
December 1, 2019
1 month
October 7, 2009
December 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasmatic and intracellular concentration of raltegravir
10 days
Secondary Outcomes (7)
Clearance, CL/F
10 days
Volume of distribution, V/F
10 days
Elimination half-life, t1/2
10 days
Area under the plasma concentration-time curve during the dosing interval AUC0-24
10 days
Maximum concentration
10 days
- +2 more secondary outcomes
Study Arms (1)
Raltegravir 800 mg / 24 hours
EXPERIMENTALRaltegravir 800 mg / 24 hours
Interventions
Eligibility Criteria
You may qualify if:
- Age \> 18 years.
- HIV documented infection.
- Stable antiretroviral treatment for at least 4 weeks.
- HIV viral load in plasma \<50 copies / mL for at least 12 weeks
- Voluntary written informed consent.
You may not qualify if:
- AIDS-defining illness in the previous 4 weeks
- Suspicion of inadequate adherence to antiretroviral therapy
- In the case of women, pregnant or breastfeeding, or non-use of contraceptives
- History or suspicion of failure to cooperate adequately
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Molto, MD,PhD
Germans Trias i Pujol Hospital
- PRINCIPAL INVESTIGATOR
Marta Valle, MD,PhD
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2009
First Posted
October 15, 2009
Study Start
November 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
December 5, 2019
Record last verified: 2019-12