Raltegravir and Atazanavir Replacing Current Suppressive Treatment Because of Side Effects in Current Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Peter J. Ruane, M.D., Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Peter J. Ruane, M.D., Inc.
ClinicalTrials.gov Identifier:
NCT00751153
First received: September 10, 2008
Last updated: October 8, 2008
Last verified: September 2008
  Purpose

Subjects with HIV who have viral suppression on current regimen but also have side effects/intolerance will change their current regimen to a combination of Raltegravir and Atazanavir and be monitored for viral and immunological response and quality of life.


Condition Intervention Phase
HIV Infections
Drug: Raltegravir and Atazanavir
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Phase 4, 48 Week Pilot Study of the Antiviral Efficacy and Tolerability of the Combination of Isentress™ and ReyatazTM When Substituted for Current Antiviral Regimen in Patients With Viral Suppression But Who Are Experiencing Adverse Events Related to Their Current Antiviral Regimen.

Resource links provided by NLM:


Further study details as provided by Peter J. Ruane, M.D., Inc.:

Primary Outcome Measures:
  • Evaluation of the proportion of patients who maintain plasma HIV viral load measurements < 400 copies/ml at week 4, 8, 12, 16, 24, 36 and 48 weeks after switching to Raltegravir and Atazanavir [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of the proportion of patients who have plasma HIV viral load measurements <50 copies/ml at week 4, 8, 12, 16, 24, 36 and 48 weeks after switching to Raltegravir and Atazanavir [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Time to virologic failure (defined as 2 consecutive VL measurements > 400 copies/ml on 2 separate clinic visits within 4 weeks) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Assessment of CD4 cell count changes at 4, 8, 12, 16, 24, 36 and 48 weeks after switching to Raltegravir and Atazanavir [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Assessment of lipid changes after change in regimen [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Determination of incidence, genotypic and phenotypic resistance patterns, in particular to Raltegravir and Atazanavir, in patients in the event of rebound viremia [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Patient adherence to a regimen of Raltegravir and Atazanavir [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Raltegravir and Atazanavir
    Rategravir 400 BID, Atazanavir 400 mg daily
Detailed Description:

Subjects with intolerance to current regimen will receive Raltegravir 400 mg twice daily and Atazanavir 400 mg daily will be monitored for viralogical and immunological outcomes, changes in lipids, renal and hepatic safety and quality of life.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • History of no PI resistance or antiretroviral failure while receiving a PI.
  • On a current antiviral regimen with plasma HIV viral load (VL) < 400 copies/ml for 4 months or longer.
  • Intolerance to or toxicity with current or alternative regimen(s) with side effects including but not limited to gastrointestinal, neurological, metabolic, or dysmorphic symptoms and/or dyslipidemia.
  • Continuously using the same regimen for 3 months prior to Screening.
  • Women of childbearing potential must be willing to use effective method(s) of contraception throughout their study participation and for 30 days following the end of the study (see Section 1.10). -Women who are postmenopausal for at least 2 years, women with total hysterectomy and women with tubal ligation are considered of non-childbearing potential.
  • Willing to adhere to the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

  • Use of any drug contraindicated in the current US package insert for Atazanavir or in the investigators brochure for Raltegravir, including PPI inhibitors.
  • Use of any investigational drug up to 4 weeks prior to screening.
  • Prior or current therapy with Raltegravir.
  • Allergy to Raltegravir or Atazanavir
  • History of medication non-compliance significant to the study regimen as deemed significant by the investigator.
  • Known achlorhydria that would inhibit the absorption of Atazanavir
  • Concurrent active chronic Hepatitis B requiring therapy with 3TC, FTC or Tenofovir (entecavir permitted).
  • AST or ALT >5 times ULN
  • Calculated CrCl < 30 ml/min.
  • Female subject who is pregnant or breastfeeding.
  • General medical condition that may interfere with the assessments and completion of the trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751153

Contacts
Contact: Peter J Ruane, MB 3239541072 pjruane@lightsourcemedical.com
Contact: Brian Alas 3239541072 balas@lightsourcemedical.com

Locations
United States, California
Medical Practice of Peter Ruane MB Recruiting
Los Angeles, California, United States, 90036
Sponsors and Collaborators
Peter J. Ruane, M.D., Inc.
Investigators
Principal Investigator: Peter J Ruane, MB Peter J Ruane MD Inc
  More Information

No publications provided

Responsible Party: Peter J Ruane, Peter J Ruane MD Inc
ClinicalTrials.gov Identifier: NCT00751153     History of Changes
Other Study ID Numbers: Merck IISP #33040
Study First Received: September 10, 2008
Last Updated: October 8, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Peter J. Ruane, M.D., Inc.:
drug substitution
Raltegravir
Atazanavir
treatment Experienced

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
Antiviral Agents
Atazanavir
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on April 15, 2014