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Safety and Tolerance of Indinavir plus Ritonavir in HIV-Positive Patients Failing Therapy with Amprenavir, Nelfinavir, or Saquinavir Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Safety and Tolerance of Indinavir plus Ritonavir in HIV-Positive Patients Failing Therapy with Amprenavir, Nelfinavir, or Saquinavir conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Safety and Tolerance of Indinavir plus Ritonavir in HIV-Positive Patients Failing Therapy with Amprenavir, Nelfinavir, or Saquinavir Clinical research trials and Safety and Tolerance of Indinavir plus Ritonavir in HIV-Positive Patients Failing Therapy with Amprenavir, Nelfinavir, or Saquinavir health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Safety and Tolerance of Indinavir plus Ritonavir in HIV-Positive Patients Failing Therapy with Amprenavir, Nelfinavir, or Saquinavir. Safety and Tolerance of Indinavir plus Ritonavir in HIV-Positive Patients Failing Therapy with Amprenavir, Nelfinavir, or Saquinavir Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Safety and Tolerance of Indinavir plus Ritonavir in HIV-Positive Patients Failing Therapy with Amprenavir, Nelfinavir, or Saquinavir clinical trial. Human subjects frequently get the finest healthcare available for their Safety and Tolerance of Indinavir plus Ritonavir in HIV-Positive Patients Failing Therapy with Amprenavir, Nelfinavir, or Saquinavir condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and Tolerance of Indinavir plus Ritonavir in HIV-Positive Patients Failing Therapy with Amprenavir, Nelfinavir, or Saquinavir  Safety and Tolerance of Indinavir plus Ritonavir in HIV-Positive Patients Failing Therapy with Amprenavir, Nelfinavir, or Saquinavir
Safety and Tolerance of Indinavir plus Ritonavir in HIV-Positive Patients Failing Therapy with Amprenavir, Nelfinavir, or Saquinavir
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: In this study, the protease inhibitors indinavir (IDV) and ritonavir (RTV) will be studied in patients who have high levels of virus while taking other protease inhibitors. The purpose of this study is to see how the body takes in, distributes, and gets rid of IDV and RTV. This study will also look at any side effects that IDV or RTV causes. IDV is an effective anti-HIV drug, but it can be difficult for patients to take. For IDV to work against HIV, it must be taken 3 times a day at a high dose and with a certain diet. Doctors believe IDV may be easier to take if it is given with RTV. Patients who take IDV and RTV together may be able to take IDV only twice a day and at a lower dose. This study will gather information about the safety and side effects of using IDV and RTV together.
Details: IDV, a protease inhibitor, has shown excellent clinical and virologic responses when combined with 2 nucleoside analogues. Although effective, the pharmacokinetics of IDV make it difficult to use in many patients. The drug has a short half-life and requires administration in high doses every 8 hours with significant dietary restrictions. Research has shown that IDV kinetics can be improved significantly by the addition of RTV, allowing for administration of IDV at lower doses every 12 hours. The half-life of IDV is prolonged 3- to 5-fold when administered with RTV. Based on these results, it is reasonable to study this combination as a twice-daily dosing regimen. Patients are randomized to receive 1 of 2 doses of IDV/RTV for 24 weeks (Arms A and B). All patients also receive 2 nucleoside reverse transcriptase inhibitors (NRTIs). The NRTIs are not provided by the study. Clinical assessments take place at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 which includes a virology assessment. [AS PER AMENDMENT 4/21/00: Patients who experience a confirmed virologic failure (defined in protocol) and elect to remain on study treatment, are followed through Week 24. Patients who experience a confirmed virologic failure and elect to discontinue study treatment will have a final evaluation at the time of treatment discontinuation.] Patients are hospitalized for 12 hours at the Week 2 study visit for an intensive pharmacokinetic analysis.
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Are at least 18 years old. - Have a viral load (level of HIV in the blood) of at least 500 copies/ml but no more than 100,000 copies/ml within 45 days of study entry. - Have been taking the following anti-HIV drug combination for at least 12 weeks before study entry: 2 NRTIs plus amprenavir (APV), nelfinavir (NFV), saquinavir (SQV), or NFV plus SQV. - Are naive to at least 1 NRTI. This means that there is at least 1 NRTI that the patient has not taken for more than 14 days. In the case of lamivudine (3TC), naive means that the patient has never taken this drug. - Are willing and able to drink 1.5 liters (a little over 1.5 quarts) of water or other fluids a day. - Agree to use an effective barrier method of birth control (such as condoms) during the study and for 3 months after. Exclusion Criteria Patients will not be eligible for this study if they: - Have taken protease inhibitors other than APV, NFV, SQV, or NFV plus SQV. - Are resistant to the effects of IDV or RTV, as shown by a blood test. (Patients whose viral load is between 500 and 1,000 copies/ml will not need to be tested.) - Have any active opportunistic (AIDS-related) infection in the 14 days before study entry. - Have any medical condition or history of disease that would prevent them from completing the study or put them at risk. - Have cancer that requires chemotherapy. - Have an active infection that requires treatment in the 14 days before study entry. - Have a fever for a week or more in the 30 days before study entry. - Have taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) in the 30 days before study entry. - Have received a vaccine in the 21 days before study entry. - Have received an experimental drug or a drug that affects the immune system in the 30 days before study entry. - Have taken or plan to take certain other medications that may affect the study. - Are pregnant or breast-feeding.
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
JohnGerber, Study Chair,
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of Washington
Seattle, Washington, 98104
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Marin County Specialty Clinic
San Rafael, California, 94903
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Wishard Hosp/Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Univ of California, San Diego
San Diego, California, 92103
United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Denver Dept of Health and Hosps
Denver, Colorado, 80262
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Chelsea Ctr
New York City, New York, 10021
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390
United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Additional Information:
Study ID Numbers: ACTG A5055; AACTG A5055
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001133
Other Hiv Infections Studies:
1. Effectiveness of Adding Interleukin-2 to Anti-HIV Drugs in Patients Recently Infected with HIV
2. A Study of BV-araU in the Treatment of Varicella-Zoster Viral Disease (VZV) in HIV-Infected Children Who Have Not Had Success with or Who Cannot Take Other Treatments for VZV
3. Education Program to Promote Female Condom Use
4. A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients with HIV Infection
5. SU5416 in Patients with AIDS-Related Kaposi's Sarcoma Who Have Not Responded to Treatment
Related Studies:
Other HIV Infections Clinical Trials
Other Colorado Clinical Trials
Other Denver Clinical Trials
Safety and Tolerance of Indinavir plus Ritonavir in HIV-Positive Patients Failing Therapy with Amprenavir, Nelfinavir, or Saquinavir
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