The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year
The Antiviral Effect of Switching From Hard Capsule Saquinavir (SQVhc) to the Soft Gelatin Capsule of Saquinavir (SQVsc) Versus Switching to Indinavir (IDV) After 1 Year of Saquinavir Use
2 other identifiers
interventional
144
1 country
16
Brief Summary
To determine, in HIV-infected patients, whether switching to a new soft gelatin capsule formulation of saquinavir or to indinavir following prolonged use of the original hard capsule formulation of saquinavir results in an acute decrease in plasma HIV RNA. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
16 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
Study Completion
Last participant's last visit for all outcomes
October 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- 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:
- +3 more criteria
You may not qualify if:
- Co-existing Condition:
- 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.
- +37 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Stanford CRS
Palo Alto, California, 94304, United States
Ucsf Aids Crs
San Francisco, California, 94110, United States
Harbor-UCLA Med. Ctr. CRS
Torrance, California, 90502, United States
University of Colorado Hospital CRS
Aurora, Colorado, 80045, United States
Univ. of Miami AIDS CRS
Miami, Florida, 33136, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114, United States
Washington U CRS
St Louis, Missouri, 63110, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63112, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14260, United States
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, 10003, United States
NY Univ. HIV/AIDS CRS
New York, New York, 10016, United States
Univ. of Rochester ACTG CRS
Rochester, New York, 14642, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, 43210, United States
University of Washington AIDS CRS
Seattle, Washington, 98104, United States
Related Publications (6)
Saquinavir update. Treat Rev. 1997 Aug;(No 25):6.
PMID: 11364616BACKGROUNDSaquinavir switch study stopped. Treat Rev. 1997 Apr;(No 24):6.
PMID: 11364285BACKGROUNDGilden D. Spring cleaning in trial land. GMHC Treat Issues. 1997 Mar;11(3):4-7.
PMID: 11364275BACKGROUNDPara 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)
BACKGROUNDSevin 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.
PMID: 10882582BACKGROUNDPara 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.
PMID: 10950766BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Para MF
- STUDY CHAIR
Collier A
- STUDY CHAIR
Coombs R
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
October 1, 1998
Last Updated
November 4, 2021
Record last verified: 2021-10