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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00718536

Enrollment

Registered

2008-07-18

Start date

2008-08-31

Completion date

2009-01-31

Last updated

2019-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Atazanavir, Raltegravir, once-daily, pharmacokinetics, HIV

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.

Interventions

DRUGAddition of raltegravir 800 mg QD to HAART

Addition of raltegravir 800 mg QD to HAART

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Raltegravir area under the curve (AUC) 24 hours and Cmin	Day 10

Secondary

Measure	Time frame
Adverse events	Baseline (BL), Day 10
Adherence	BL, Day 10

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026