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
Recruitment status was Recruiting
Sponsor:
Peter J. Ruane, M.D., Inc.
Information provided by:
Peter J. Ruane, M.D., Inc.
ClinicalTrials.gov Identifier:
NCT00751153
First received: September 10, 2008
Last updated: October 8, 2008
Last verified: September 2008
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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 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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:
Detailed Description:
-
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.
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
No publications provided
| Responsible Party: | Peter J Ruane, Peter J Ruane MD Inc |
| ClinicalTrials.gov Identifier: | NCT00751153 History of Changes |
| Other Study ID Numbers: | Merck IISP #33040 |
| Study First Received: | September 10, 2008 |
| Last Updated: | October 8, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Peter J. Ruane, M.D., Inc.:
|
drug substitution Raltegravir Atazanavir treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Antiviral Agents Atazanavir Anti-Infective Agents Therapeutic Uses Pharmacologic Actions HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents |
ClinicalTrials.gov processed this record on June 18, 2013