We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00718536
Recruitment Status : Completed
First Posted : July 18, 2008
Last Update Posted : April 10, 2009
Sponsor:
Information provided by:

Study Description
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.

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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2008
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Raltegravir area under the curve (AUC) 24 hours and Cmin [ Time Frame: Day 10 ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Baseline (BL), Day 10 ]
  2. Adherence [ Time Frame: BL, Day 10 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: FUNDACIO LLUITA CONTRA LA SIDA, LLuita Sida Foundation
ClinicalTrials.gov Identifier: NCT00718536     History of Changes
Other Study ID Numbers: RALqd-ATV
First Posted: July 18, 2008    Key Record Dates
Last Update Posted: April 10, 2009
Last Verified: April 2009

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Atazanavir Sulfate
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
HIV Protease Inhibitors
Protease Inhibitors