Status:
COMPLETED
Clinical Trial Assessing Once Daily Raltegravir Administration (800 mg QD) in HIV-1-Infected Patients Receiving Unboosted Atazanavir (400 mg QD)- Based Antiretroviral Therapy
Lead Sponsor:
Germans Trias i Pujol Hospital
Collaborating Sponsors:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The co-administration of raltegravir with medicinal products that are knouwn to be potent UGT1A1 inhibitors, such as atazanavir, may increase plasma levels of raltegravir. So once daily raltegravir (8...
Detailed Description
Treatment adherence is crucial for the effectiveness of antiretroviral therapy, and, in an attempt to promote treatment adherence by the patients, once daily (QD) regimens are preferred rather than tw...
Eligibility Criteria
Inclusion
- Patients aged 18 to 65 years old with documented HIV-1 infection.
- Patients on antiretroviral regimen that includes atazanavir 400mg QD for at least 4 weeks.
- Complete virological suppression (\<50 copies/mL) for at least 12 months.
- Voluntary written informed consent.
- Ability of compliance with visit schedule.
Exclusion
- AIDS defining condition within 4 weeks prior to the initiation of the study.
- Concomitant treatment with ritonavir as well as with inducers (NNRTI, rifampin, carbamazepine, phenytoin, phenobarbital, valproic acid, etc) or inhibitors (probenecid, etc) of the uridine diphosphate glucuronyl transferase within 2 weeks before the screening visit.
- Concomitant therapy with tenofovir.
- History or suspected poor adherence to HAART.
- History of drug allergy to raltegravir
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00718536
Start Date
August 1 2008
End Date
January 1 2009
Last Update
December 5 2019
Active Locations (1)
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1
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916