Raltegravir and Atazanavir Replacing Current Suppressive Treatment Because of Side Effects in Current Treatment - Full Text View

Sponsored by:	Peter J. Ruane, M.D., Inc.
Information provided by:	Peter J. Ruane, M.D., Inc.
ClinicalTrials.gov Identifier:	NCT00751153

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 IV

MedlinePlus related topics: AIDS

Drug Information available for: Raltegravir Atazanavir sulfate BMS 232632

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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.

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:

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

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

Keywords provided by Peter J. Ruane, M.D., Inc.:

drug substitution
Raltegravir
Atazanavir
treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Atazanavir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 16, 2009