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A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy Clinical research trials and A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy. A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy clinical trial. Test subjects typically receive the most expert healthcare available for their A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.

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A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy



A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy

For Condition: HIV Infections
Status: Recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: The purpose of this clinical research study is to learn if atazanavir is associated with serum LDL cholesterol in HIV-infected subjects following a substitution of atazanavir for their previously administered protease inhibitor.
Details:
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Key Inclusion Criteria: - Must be on current HIV treatment regimen at least 3 to 6 months prior to study (this must be one protease inhibitor, or ritonavir-boosted protease inhibitor, and two nucleoside reverse transcriptase inhibitors) must be subject's first PI ever received - Plasma HIV-1 RNA level < 50 c/mL within 3 to 6 months prior to study start - Fasting LDL cholesterol > 130 mg/dL Key Exclusion Criteria: - WOCBP who do not use effective barrier contraception for any reason - Women who are pregnant or breast feeding - A life expectancy < 12 months - Presence of a newly diagnosed HIV-related OI or any medical condition requiring acute therapy at the time of enrollment - Cushing's Syndrome - Uncontrolled diabetes mellitus, history of diabetic ketoacidosis or hyperosmolar syndrome - Untreated hypothyroidism or hyperthyroidism - Nephrotic syndrome or significant proteinuria - Obstructive liver disease - Active alcohol or substance abuse - Proven or suspected acute hepatitis in the 30 days prior to study entry - Intractable diarrhea (greater than or equal to 6 loose stols/day for at least 7 consecutive days) within 30 days prior to study start - History of acute or chronic pancreatitis - Inability to swallow capsules - Presence of cardiomyopathy - Known history of prolonged QTc interval - Any of the following: a) clinical symptoms potentially related to heart block b) heart rate < 40 bpm c) any of the following EKG abnormalities: i) pause length > 3 seconds ii) second or third degree AV heart block iii) QTc interval > 450 msec for males iv) QTc interval > 470 msec for females - Fasting serum triglyceride level > 750 mg/dL - Any of the following lab values within 2 weeks of starting study drug: a) serum creatinine greater to or equal to 1.5 times the upper limit of normal b) total serum lipase greater than or equal to 1.4 times the upper limit of normal c) liver transaminases greater than or equal to 3 times the upper limit of normal d) total serum bilirubin greater than or equal to 1.5 times the upper limit of normal - Hypersensitivity to any component of the formulation of study drug - Use of any lipid-lowering agent within 4 weeks prior or during study - Use of a PI-containing ARV regimen prior to entry which is comprised of more than one PI - Inclusion of an NNRTI in the PI-containing regimen - Prisoners or subjects involuntary incarcerated for treatment of psychiatric or physical illness
Total Enrollment: 

Location and Contact Information:

Local Institution *Recruiting*
Cleveland,  Ohio, 
United States
Recruiting  

Local Institution *Recruiting*
Oklahoma City,  Oklahoma, 
United States
Recruiting  

Local Institution *Recruiting*
Phoenix,  Arizona, 
United States
Recruiting  

Local Institution *Recruiting*
Boston,  Massachusetts, 
United States
Recruiting  

Local Institution *Recruiting*
Ft. Lauderdale,  Florida, 
United States
Recruiting  

Local Institution *Recruiting*
Minneapolis,  Minnesota, 
United States
Recruiting  

Local Institution *Recruiting*
Philadelphia,  Pennsylvania, 
United States
Recruiting  

Local Institution *Recruiting*
Washington D.C.,  District of Columbia, 
United States
Recruiting  

Local Institution *Recruiting*
Columbia,  South Carolina, 
United States
Recruiting  

Local Institution *Recruiting*
Tampa,  Florida, 
United States
Recruiting  

Local Institution *Recruiting*
Ft. Worth,  Texas, 
United States
Recruiting  

Local Institution *Recruiting*
Altamonte Springs,  Florida, 
United States
Recruiting  

Local Institution *Recruiting*
St. Louis,  Missouri, 
United States
Recruiting  

Local Institution *Recruiting*
New York City,  New York, 
United States
Recruiting  

Local Institution *Recruiting*
Huntersville,  North Carolina, 
United States
Recruiting  

Local Institution *Recruiting*
West Hollywood,  California, 
United States
Recruiting  

Local Institution *Recruiting*
Miami,  Florida, 
United States
Recruiting  

Local Institution *Recruiting*
East Orange,  New Jersey, 
United States
Recruiting  

Local Institution *Recruiting*
Houston,  Texas, 
United States
Recruiting  


Additional Information:
Study ID Numbers:
  AI424-067; 
Study Start Date: December 2002
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067782

Other Hiv Infections Studies:
1. A Study on Amprenavir in Combination with Other Anti-HIV Drugs in HIV-Positive Patients

2. An Investigational Combination Vaccine Given to People Who Are Not Infected with HIV

3. The Effectiveness of Ritonavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients

4. Therapeutic Drug Monitoring and Viral Resistance Testing in the Treatment of HIV-Infected Children

5. Evaluation of the Safety and Tolerance of Immunotherapy With Autologous, Ex-Vivo Expanded, HIV-Specific Cytotoxic T-Cells in HIV-Infected Patients With CD4+ Counts Between 100-400/mm3

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A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on their First PI-Based Antiretroviral Therapy

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