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

Study Overview
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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.

Official Title
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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.

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Raltegravir and Atazanavir


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Raltegravir and Atazanavir|Rategravir 400 BID, Atazanavir 400 mg daily|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 48 weeks | 
| Time to virologic failure (defined as 2 consecutive VL measurements > 400 copies/ml on 2 separate clinic visits within 4 weeks) |  | 48 weeks | 
| Assessment of CD4 cell count changes at 4, 8, 12, 16, 24, 36 and 48 weeks after switching to Raltegravir and Atazanavir |  | 48 weeks | 
| Assessment of lipid changes after change in regimen |  | 48 weeks | 
| Determination of incidence, genotypic and phenotypic resistance patterns, in particular to Raltegravir and Atazanavir, in patients in the event of rebound viremia |  | 48 weeks | 
| Patient adherence to a regimen of Raltegravir and Atazanavir |  | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug substitution, Raltegravir, Atazanavir, treatment Experienced