Safety and Tolerance of Indinavir Plus Ritonavir in HIV-Positive Patients Failing Therapy With Amprenavir, Nelfinavir, or Saquinavir
A Phase I/II, Randomized, Open-Label Study of the Safety and Pharmacokinetics of Indinavir + Ritonavir Therapy in HIV-Infected Subjects Failing Amprenavir, Nelfinavir, Saquinavir, or Nelfinavir/Saquinavir Combination Therapy
4 other identifiers
interventional
50
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedNovember 1, 2021
October 1, 2021
January 17, 2000
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Alabama Therapeutics CRS
Birmingham, Alabama, 35294, United States
USC CRS
Los Angeles, California, 900331079, United States
Ucsf Aids Crs
San Francisco, California, 94110, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287, United States
NY Univ. HIV/AIDS CRS
New York, New York, 10016, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, 452670405, United States
Pitt CRS
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (3)
Acosta EP, Wu H, Hammer SM, Yu S, Kuritzkes DR, Walawander A, Eron JJ, Fichtenbaum CJ, Pettinelli C, Neath D, Ferguson E, Saah AJ, Gerber JG; Adult AIDS Clinical Trials Group 5055 Protocol Team. Comparison of two indinavir/ritonavir regimens in the treatment of HIV-infected individuals. J Acquir Immune Defic Syndr. 2004 Nov 1;37(3):1358-66. doi: 10.1097/00126334-200411010-00004.
PMID: 15483465RESULTKing JR, Gerber JG, Fletcher CV, Bushman L, Acosta EP. Indinavir protein-free concentrations when used in indinavir/ritonavir combination therapy. AIDS. 2005 Jul 1;19(10):1059-63. doi: 10.1097/01.aids.0000174452.78497.54.
PMID: 15958837RESULTWu H, Huang Y, Acosta EP, Park JG, Yu S, Rosenkranz SL, Kuritzkes DR, Eron JJ, Perelson AS, Gerber JG. Pharmacodynamics of antiretroviral agents in HIV-1 infected patients: using viral dynamic models that incorporate drug susceptibility and adherence. J Pharmacokinet Pharmacodyn. 2006 Aug;33(4):399-419. doi: 10.1007/s10928-006-9006-4. Epub 2006 Apr 1.
PMID: 16583266RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
John G. Gerber
- STUDY CHAIR
Edward P. Acosta
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2000
First Posted
August 31, 2001
Study Completion
August 1, 2006
Last Updated
November 1, 2021
Record last verified: 2021-10