|
Phase III Open Label Atazanavir (BMS-232632) in Combination with Ritonavir or Saquinavir, and Lopinavir/Ritonavir, each with Tenofovir and a Nucleoside in Subjects with HIV Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Phase III Open Label Atazanavir (BMS-232632) in Combination with Ritonavir or Saquinavir, and Lopinavir/Ritonavir, each with Tenofovir and a Nucleoside in Subjects with HIV conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase III Open Label Atazanavir (BMS-232632) in Combination with Ritonavir or Saquinavir, and Lopinavir/Ritonavir, each with Tenofovir and a Nucleoside in Subjects with HIV Clinical research trials and Phase III Open Label Atazanavir (BMS-232632) in Combination with Ritonavir or Saquinavir, and Lopinavir/Ritonavir, each with Tenofovir and a Nucleoside in Subjects with HIV medical trials take place in many of places 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 usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Phase III Open Label Atazanavir (BMS-232632) in Combination with Ritonavir or Saquinavir, and Lopinavir/Ritonavir, each with Tenofovir and a Nucleoside in Subjects with HIV. Phase III Open Label Atazanavir (BMS-232632) in Combination with Ritonavir or Saquinavir, and Lopinavir/Ritonavir, each with Tenofovir and a Nucleoside in Subjects with HIV Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Phase III Open Label Atazanavir (BMS-232632) in Combination with Ritonavir or Saquinavir, and Lopinavir/Ritonavir, each with Tenofovir and a Nucleoside in Subjects with HIV clinical trial. Test subjects typically obtain the finest healthcare available for their Phase III Open Label Atazanavir (BMS-232632) in Combination with Ritonavir or Saquinavir, and Lopinavir/Ritonavir, each with Tenofovir and a Nucleoside in Subjects with HIV condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Phase III Open Label Atazanavir (BMS-232632) in Combination with Ritonavir or Saquinavir, and Lopinavir/Ritonavir, each with Tenofovir and a Nucleoside in Subjects with HIV  Phase III Open Label Atazanavir (BMS-232632) in Combination with Ritonavir or Saquinavir, and Lopinavir/Ritonavir, each with Tenofovir and a Nucleoside in Subjects with HIV
Phase III Open Label Atazanavir (BMS-232632) in Combination with Ritonavir or Saquinavir, and Lopinavir/Ritonavir, each with Tenofovir and a Nucleoside in Subjects with HIV
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: The purpose of this study is to learn how well atazanavir works in combination with ritonavir or saquinavir with tenofovir and a nucleoside to reduce the viral load of treatment experienced subjects with HIV. There is a comparison arm with lopinavir/ritonavir and tenofovir and a nucleoside.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Virologic failure to two or more HAART regimens that, in total, have included at least one drug from all approved classes (PI, NNRTI, NRTI): a. Currently on a failing HAART regimen with two qualifying plasma viral load measurements (hospital/clinic value withing 4 weeks of screening with viral load equivalent to =/>1,000c/mL on the Roche Amplicor[TM] and central lab measurements of =/>1,000C.mL (Roche Amplicor[TM]) within 4 weeks of randomization b. CD4 cell count =/>50 cells/mm3 obtained within 4 weeks prior to randomization - =/> 16 years of age (or minimum age as determined by local regulations or as legal requirements dictate); - History of prior virologic response to at least one HAART regimen, defined as a 1.0 log10 decline or a decline in viral load to< 400 C/mL by Roche Amplicor or <500 c/mL by Chiron bDNA - Both females of child bearing potential and males must utilize effective barrier contraception to reduce transmission of sexually transmitted disease, including HIV. Other contraception in addition to barrier methods is permitted (but see last paragraph Section 5.2.1); interaction between atazanavir and oral contraceptives have not been studied. - Subjects must be able to provide written informed consent; - Subjects should be available for follow-up for a period of at least 48 weeks - Baseline laboratory values measured within 2 weeks prior to initiating study drugs as follows: a. serum creatine <1.5 times the upper limit of normal b.total serum lipase < 1.4 times the upper limit of normal c. liver enzymes (AST, ALT) < 3 times the upper limit of normal d. total serum bilirubin < 1.5 times the upper limit of normal Exclusion Criteria: - Prior use (=/>3 days) of atazanavir, TVF or LPV/RTV; if hx of SQV then must be phenotypically sensitive - the current failing antiretroviral regimen must have been administered for at least eight weeks at he initiation of screening and must not include both a PI and NNRTI - Presence of a newly diagnosed HIV-related opportunistic infection or any medical requiring acute therapy at the time of enrollment - Proven or suspected acute hepatitis in the 30 days prior to study entry. Subjects with chronic hepatitis are eligible provided that their liver function enzymes (ALT/AST) are <3xULN - Previous therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatoxic, hepatoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment ot therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4. - Active alcohol or substance use sufficient, in the Investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis - Intractable diarrhea (=/> 6 loose stools/day for at least 7 days consecutive days) within 30 days prior to study entry - Pregnancy or breast-feeding - History of hemophilia - Presence of cardiomyopathy - Any one of the following: a. QTc interval > 450 msec on the screening EKG b. Heart rate < 40 bpm c. Pause length > 3 seconds seen on EKG d. Clinical symptoms potentially related to heart block e. Third degree heart block - History of acute or chronic pancreatitis - If choosing ddI or d4T as the NRTI: History or signs and symptoms of bilateral peripheral neuropathy =/> Grade 2 at the time of screening - Inability to tolerate oral medications - Any other clinical conditions or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for study or unable to comply with the dosing requirements.
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: AI424-045;
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035932
Other Hiv Infections Studies:
1. An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies
2. Safety and Acceptability of PRO 2000 Vaginal Gel in HIV Uninfected Women in India
3. Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with HIV infection and modestly detectable viral load.
4. A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
5. Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT / ddI or AZT / ddC) Anti-Retroviral Therapy
Related Studies:
Other HIV Infections Clinical Trials
Other Florida Clinical Trials
Other Ft. Lauderdale Clinical Trials
Phase III Open Label Atazanavir (BMS-232632) in Combination with Ritonavir or Saquinavir, and Lopinavir/Ritonavir, each with Tenofovir and a Nucleoside in Subjects with HIV
|
|
|
|
|
|
|
|
