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

NCT ID: NCT00751153

Last Updated: 2008-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Keywords

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drug substitution Raltegravir Atazanavir treatment Experienced

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Raltegravir and Atazanavir

Rategravir 400 BID, Atazanavir 400 mg daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peter J. Ruane, M.D., Inc.

OTHER

Sponsor Role lead

Responsible Party

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Peter J Ruane MD Inc

Principal Investigators

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Peter J Ruane, MB

Role: PRINCIPAL_INVESTIGATOR

Peter J Ruane MD Inc

Locations

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Medical Practice of Peter Ruane MB

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Peter J Ruane, MB

Role: CONTACT

Phone: 3239541072

Email: [email protected]

Brian Alas

Role: CONTACT

Phone: 3239541072

Email: [email protected]

Other Identifiers

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Merck IISP #33040

Identifier Type: -

Identifier Source: org_study_id