The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year
NCT ID: NCT00000848
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
144 participants
INTERVENTIONAL
1998-10-31
Brief Summary
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Resistance to anti-HIV agents occurs with increasing duration of use. In vitro studies have shown that cross-resistance occurs among protease inhibitors, although no clinical trials have been conducted to examine antiretroviral activity with sequential use of protease inhibitors or to determine whether saquinavir resistance can be overcome with higher concentrations of the drug.
Detailed Description
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Patients who are currently receiving hard capsule saquinavir are randomized to continue receiving hard capsule saquinavir or to switch to soft gelatin capsule saquinavir or indinavir. At week 8, patients receiving the hard capsule formulation will switch to open-label indinavir for weeks 8-24. Patients on the other two arms will remain on their assigned regimen for the entire 24 weeks unless they have no virologic response by week 8, in which case they will be crossed-over to open-label therapy with the alternative drug (i.e., either soft gelatin capsule saquinavir or indinavir).
AS PER AMENDMENT 12/23/96: Viral RNA from weeks 16 and 24 will be assayed in batch after week 24. Patients who exhibit an antiviral response based on this assay will be allowed to continue their current drug assignment for a total of 12 months.
AS PER AMENDMENT 5/7/97: Based on an interim analysis performed after 72 patients had completed 8 weeks of therapy, the study was closed as of March 7, 1997. Patients currently enrolled may stop their participation in the trial and seek other anti-retroviral therapies or may continue on study. Patients on hard capsule saquinavir who remain on study will be switched to indinavir at 8 weeks. Patients on soft gel capsule saquinavir may switch immediately to indinavir or, when results of HIV RNA and CD4 cell counts are available, may choose to switch to indinavir or remain on soft gel capsule saquinavir. Patients receiving indinavir will continue that agent. Follow-up for all patients will end on 7/4/97.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Indinavir sulfate
Saquinavir
Eligibility Criteria
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Inclusion Criteria
Required:
* PCP prophylaxis if CD4 count \<= 200 cells/mm3.
Allowed:
* Intralesional therapy for KS.
* Vitamins.
* Nucleoside RT inhibitors, provided regimen remains stable for first 8 weeks of study.
Concurrent Treatment:
Allowed:
* Acupuncture.
* Visualization techniques.
Patients must have:
* HIV infection.
* Prior hard capsule saquinavir at 1800 mg/day for more than 1 year.
Prior Medication:
Allowed:
* Prior saquinavir.
* Prior antiretrovirals, excluding protease inhibitors other than saquinavir.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Psychological condition or medical instability that would interfere with study evaluation or procedures.
AS PER AMENDMENT 5/7/97:
* Active tuberculosis.
Concurrent Medication:
Excluded:
* Protease inhibitors other than study drugs.
* Non-nucleoside RT inhibitors.
* Interferon.
* Interleukins.
* GM-CSF.
* HIV vaccines.
* Systemic cytotoxic chemotherapy.
* Investigational drugs other than study medications.
* Rifabutin.
* Rifampin.
* Midazolam.
* Triazolam.
* Ketoconazole.
* Delavirdine.
* Cisapride.
* Terfenadine.
* Astemizole.
AS PER AMENDMENT 5/7/97:
* Nevirapine.
Patients with the following prior conditions are excluded:
* Unexplained fever \> 38.5 C for any 7 days within 30 days prior to study entry.
* Diarrhea persisting for 15 days within 30 days prior to study entry.
Prior Medication:
Excluded:
* Any prior protease inhibitor other than saquinavir.
Excluded within the past 2 months.
* Change in antiretroviral regimen.
* Systemic chemotherapy for KS.
Excluded within the past month:
* Non-nucleoside RT inhibitors.
* Interferons.
* Interleukins.
* HIV vaccines.
* Experimental therapies.
Excluded within the past 2 weeks:
* Rifabutin.
* Cisapride.
* Terfenadine.
* Astemizole.
* Midazolam.
* Triazolam.
* Oral ketoconazole.
* Delavirdine.
* Acute therapy for infection or other medical illness.
Active substance abuse that would interfere with study evaluation or procedures.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Para MF
Role: STUDY_CHAIR
Collier A
Role: STUDY_CHAIR
Coombs R
Role: STUDY_CHAIR
Locations
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Stanford CRS
Palo Alto, California, United States
Ucsf Aids Crs
San Francisco, California, United States
Harbor-UCLA Med. Ctr. CRS
Torrance, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Univ. of Miami AIDS CRS
Miami, Florida, United States
Northwestern University CRS
Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States
Washington U CRS
St Louis, Missouri, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, United States
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States
NY Univ. HIV/AIDS CRS
New York, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States
University of Washington AIDS CRS
Seattle, Washington, United States
Countries
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References
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Saquinavir update. Treat Rev. 1997 Aug;(No 25):6.
Saquinavir switch study stopped. Treat Rev. 1997 Apr;(No 24):6.
Gilden D. Spring cleaning in trial land. GMHC Treat Issues. 1997 Mar;11(3):4-7.
Para MF, Coombs R, Collier A, Glidden D, Bassett R, Duff F, Boucher C, Leavitt RY, Condra J, Pettinelli C. Relationship of baseline genotype to RNA response in ACTG 333 after switching from long term saquinavir (SQVhc) to indinavir (IDV) or saquinavir soft gelatin capsule (SQVsgc). Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:175 (abstract no 511)
Sevin AD, DeGruttola V, Nijhuis M, Schapiro JM, Foulkes AS, Para MF, Boucher CA. Methods for investigation of the relationship between drug-susceptibility phenotype and human immunodeficiency virus type 1 genotype with applications to AIDS clinical trials group 333. J Infect Dis. 2000 Jul;182(1):59-67. doi: 10.1086/315673. Epub 2000 Jul 6.
Para MF, Glidden DV, Coombs RW, Collier AC, Condra JH, Craig C, Bassett R, Leavitt R, Snyder S, McAuliffe V, Boucher C. Baseline human immunodeficiency virus type 1 phenotype, genotype, and RNA response after switching from long-term hard-capsule saquinavir to indinavir or soft-gel-capsule saquinavir in AIDS clinical trials group protocol 333. J Infect Dis. 2000 Sep;182(3):733-43. doi: 10.1086/315769. Epub 2000 Aug 14.
Other Identifiers
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11305
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 333
Identifier Type: -
Identifier Source: org_study_id