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

September 10, 2008
October 8, 2008
March 2008
October 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00751153 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Raltegravir and Atazanavir Replacing Current Suppressive Treatment Because of Side Effects in Current Treatment
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.

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Raltegravir and Atazanavir
Rategravir 400 BID, Atazanavir 400 mg daily
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2009
October 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Peter J Ruane, MB 3239541072 pjruane@lightsourcemedical.com
Contact: Brian Alas 3239541072 balas@lightsourcemedical.com
United States
 
NCT00751153
Merck IISP #33040
No
Peter J Ruane, Peter J Ruane MD Inc
Peter J. Ruane, M.D., Inc.
Not Provided
Principal Investigator: Peter J Ruane, MB Peter J Ruane MD Inc
Peter J. Ruane, M.D., Inc.
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP