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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 certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on 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 medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like 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 acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes 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. Participants frequently obtain 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, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.

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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

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3. Effect of an Anti-inflammatory Drug on Gut Mucosa in HIV Infected Patients

4. A Pilot/Dose-Finding Study of the Toxicity, Anti-Kaposi's Sarcoma (KS) Activity, and Immunologic Activity of Interleukin-12 Administered to Patients with AIDS-Associated KS

5. An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex

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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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