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
Information provided by:
Peter J. Ruane, M.D., Inc.
First received: September 10, 2008
Last updated: October 8, 2008
Last verified: September 2008
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.
Drug: Raltegravir and Atazanavir
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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.
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||October 2009 (Final data collection date for primary outcome measure)
Drug: Raltegravir and Atazanavir
Rategravir 400 BID, Atazanavir 400 mg daily
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751153
|Medical Practice of Peter Ruane MB
|Los Angeles, California, United States, 90036 |
Peter J. Ruane, M.D., Inc.
||Peter J Ruane, MB
||Peter J Ruane MD Inc
No publications provided
||Peter J Ruane, Peter J Ruane MD Inc
History of Changes
|Other Study ID Numbers:
||Merck IISP #33040
|Study First Received:
||September 10, 2008
||October 8, 2008
||United States: Food and Drug Administration
Keywords provided by Peter J. Ruane, M.D., Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2015
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action