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

This study has been completed.
Sponsor:
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00718536
First received: July 16, 2008
Last updated: April 8, 2009
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV Infections
 Drug: Addition of raltegravir 800 mg QD to HAART
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial Assessing Once Daily Raltegravir Administration (800 mg QD) in HIV-1-Infected Patients Receiving Unboosted Atazanavir (400 mg QD)- Based Antiretroviral Therapy

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:
  • Raltegravir area under the curve (AUC) 24 hours and Cmin [ Time Frame: Day 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Baseline (BL), Day 10 ] [ Designated as safety issue: Yes ]
  • Adherence [ Time Frame: BL, Day 10 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: August 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Addition of raltegravir 800 mg QD to HAART
 Drug: Addition of raltegravir 800 mg QD to HAART
Addition of raltegravir 800 mg QD to HAART
Other Name: HAART+RAL

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718536

Locations
Spain
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Investigators
Principal Investigator: Clotet Bonaventura, MD,PhD Lluita contra la Sida Foundation, HIV Unit
  More Information

No publications provided

Responsible Party: FUNDACIO LLUITA CONTRA LA SIDA, LLuita Sida Foundation
ClinicalTrials.gov Identifier: NCT00718536     History of Changes
Other Study ID Numbers: RALqd-ATV
Study First Received: July 16, 2008
Last Updated: April 8, 2009
Health Authority: Spain: Ministry of Health

Keywords provided by Germans Trias i Pujol Hospital:
Atazanavir
Raltegravir
once-daily
pharmacokinetics
HIV

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Atazanavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013