Clinical Trial Assessing Once Daily Raltegravir Administration (800 mg QD) in HIV-1-Infected Patients Receiving Unboosted Atazanavir (400 mg QD)- Based Antiretroviral Therapy

NCT ID: NCT00718536

Last Updated: 2019-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-01-31

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 (800 mg QD), instead of twice a day (400 mg BID), could be an appropriate therapeutic option in HIV-infected patients also receiving atazanavir-containing antiretroviral regimens. In this study, pharmacokinetic data supporting this hypothesis are recovered.

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 twice daily (BID) regimens.

The dose of 400 mg BID of raltegravir has been recently licensed for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced adult patients.

Raltegravir is eliminated mainly by metabolism via uridine diphosphate glucuronyl transferase (UGT1A1)-mediated glucuronidation pathway. Thus, co-administration of raltegravir with medicinal products that are known to be potent UGT1A1 inhibitors, such as atazanavir, may increase plasma levels of raltegravir.

Based on these data, it could be hypothesized that once daily raltegravir (800 mg QD) could be an appropriate therapeutic option in HIV-infected patients also receiving atazanavir-containing antiretroviral regimens. However, pharmacokinetic data supporting this hypothesis are lacking.

Conditions

HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Addition of raltegravir 800 mg QD to HAART

Group Type: EXPERIMENTAL

Addition of raltegravir 800 mg QD to HAART

Intervention Type: DRUG

Addition of raltegravir 800 mg QD to HAART

Interventions

Addition of raltegravir 800 mg QD to HAART

Addition of raltegravir 800 mg QD to HAART

Intervention Type: DRUG

Other Intervention Names

HAART+RAL

Eligibility Criteria

Inclusion Criteria

1. Patients aged 18 to 65 years old with documented HIV-1 infection.

2. Patients on antiretroviral regimen that includes atazanavir 400mg QD for at least 4 weeks.

3. Complete virological suppression (<50 copies/mL) for at least 12 months.

4. Voluntary written informed consent.

5. Ability of compliance with visit schedule.

Exclusion Criteria

1. AIDS defining condition within 4 weeks prior to the initiation of the study.

2. 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.

3. Concomitant therapy with tenofovir.

4. History or suspected poor adherence to HAART.

5. History of drug allergy to raltegravir

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

OTHER

Sponsor Role: collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clotet Bonaventura, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Lluita contra la Sida Foundation, HIV Unit

Locations

Germans Trias i Pujol Hospital

Badalona, Barcelona, Spain

Countries

Spain

Other Identifiers

RALqd-ATV

Identifier Type: -

Identifier Source: org_study_id