Working… Menu

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

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. Identifier: NCT00751153
Recruitment Status : Unknown
Verified September 2008 by Peter J. Ruane, M.D., Inc..
Recruitment status was:  Recruiting
First Posted : September 11, 2008
Last Update Posted : October 9, 2008
Information provided by:
Peter J. Ruane, M.D., Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: Raltegravir and Atazanavir Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : March 2008
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Intervention Details:
  • Drug: Raltegravir and Atazanavir
    Rategravir 400 BID, Atazanavir 400 mg daily

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Assessment of lipid changes after change in regimen [ Time Frame: 48 weeks ]
  5. 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 ]
  6. Patient adherence to a regimen of Raltegravir and Atazanavir [ Time Frame: 48 weeks ]

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00751153

Layout table for location contacts
Contact: Peter J Ruane, MB 3239541072
Contact: Brian Alas 3239541072

Layout table for location information
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.
Layout table for investigator information
Principal Investigator: Peter J Ruane, MB Peter J Ruane MD Inc
Layout table for additonal information
Responsible Party: Peter J Ruane, Peter J Ruane MD Inc Identifier: NCT00751153    
Other Study ID Numbers: Merck IISP #33040
First Posted: September 11, 2008    Key Record Dates
Last Update Posted: October 9, 2008
Last Verified: September 2008
Keywords provided by Peter J. Ruane, M.D., Inc.:
drug substitution
treatment Experienced
Additional relevant MeSH terms:
Layout table for 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