Raltegravir and Atazanavir Replacing Current Suppressive Treatment Because of Side Effects in Current Treatment
Phase 4
- Conditions
- HIV Infections
- Registration Number
- NCT00751153
- Lead Sponsor
- Peter J. Ruane, M.D., Inc.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method Assessment of CD4 cell count changes at 4, 8, 12, 16, 24, 36 and 48 weeks after switching to Raltegravir and Atazanavir 48 weeks 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 Patient adherence to a regimen of 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
Trial Locations
- Locations (1)
Medical Practice of Peter Ruane MB
🇺🇸Los Angeles, California, United States