Clinical trial NCT00751153: Raltegravir and Atazanavir Replacing Current Suppressive Treatment Because of Side Effects in Current 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV Infections
Keywords: drug substitution
Raltegravir
Atazanavir
treatment Experienced
Lead sponsor: Peter J. Ruane, M.D., Inc.
Sponsor class: OTHER
First posted: 2008-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
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
timeFrame: 48 weeks
Secondary outcomes:
measure: 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
timeFrame: 48 weeks
measure: Time to virologic failure (defined as 2 consecutive VL measurements > 400 copies/ml on 2 separate clinic visits within 4 weeks)
timeFrame: 48 weeks
measure: Assessment of CD4 cell count changes at 4, 8, 12, 16, 24, 36 and 48 weeks after switching to Raltegravir and Atazanavir
timeFrame: 48 weeks
measure: Assessment of lipid changes after change in regimen
timeFrame: 48 weeks
measure: Determination of incidence, genotypic and phenotypic resistance patterns, in particular to Raltegravir and Atazanavir, in patients in the event of rebound viremia
timeFrame: 48 weeks
measure: Patient adherence to a regimen of Raltegravir and Atazanavir
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Medical Practice of Peter Ruane MB
state: California
Study officials:
affiliation: Peter J Ruane MD Inc
name: Peter J Ruane, MB
role: PRINCIPAL_INVESTIGATOR
References: