A Study of Saquinavir Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: June 1997
History of Changes
To offer an investigational agent (saquinavir) to people with HIV/AIDS who are in need of
additional treatment options and are not eligible to enroll in ongoing clinical trials.
Patients who no longer benefit from existing antiretroviral therapy and who are not currently enrolled in ongoing saquinavir trials are eligible for this compassionate treatment program.
Drug : Saquinavir
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open Label International Compassionate Treatment Program for the Use of Saquinavir (R0 31-8959) Either As Monotherapy or in Combination With Other Anti-Retroviral Drugs in Patients With Proven HIV Infection|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Patients who no longer benefit from existing antiretroviral therapy and who are not currently
enrolled in ongoing saquinavir trials are eligible for this compassionate treatment program.
Patients may be registered with the program through their physicians, who will be responsible for supervising the administration of treatment; following guidelines for saquinavir dose interruption, dose reduction, or discontinuation; and assessing patient progress throughout the duration of the study. Access to saquinavir will be determined by a lottery system; 60 percent of the program slots will be reserved for patients with CD4 counts of 50 or less and the remaining 40 percent of the slots will be devoted to patients with CD4 counts between 51 and 300.
|Ages Eligible for Study:||13 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients must have:
- Sero-positivity for HIV -1 antibody by an ELISA test, with confirmation by an alternative method.
- CD4 count <= 300 cells/mm3 (within 4 weeks prior to entry).
- Signed, informed consent from a parent or legal guardian for patients < 18 years of age.
- Failed previous therapy with or be intolerant to other registered anti-retroviral drugs.
- Eligibility for any controlled clinical study of any experimental HIV therapy.
- Grade 4 hematologic and/or Grade 3 hematologic toxicity at baseline.
- Concomitant therapy and treatment should be kept at a minimum.
- Current participation in any study formally excluding concomitant treatment with
- Saquinavir can be used in combination with other registered anti-retroviral drugs such as ZDV, ddC and/or ddl. Other not yet registered anti-retroviral drugs can be used in combination with saquinavir when these drugs are widely available in the respective country or when they are allowed in combination treatment in any on-going clinical study.
- Prophylactic treatment for any opportunistic infections.
Patients with the following conditions or symptoms are excluded:
Patients with the following prior conditions are excluded:
Known hypersensitivity to saquinavir or other protease inhibitors. 1. Drugs, such as rifampin and rifabutin, which induce hepatic enzymes are likely to result in decreased levels of saquinavir and, therefore, should be avoided where possible.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002382
Locations Show More
|United States, New Jersey|
|Hoffmann - La Roche Inc|
|Nutley, New Jersey, United States, 071101199|
Sponsors and CollaboratorsHoffmann-La Roche
|Responsible Party:||Hoffmann-La Roche|
|ClinicalTrials.gov Identifier:||NCT00002382 History of Changes|
|Other Study ID Numbers:||229L|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Zalcitabine
Drug Therapy, Combination
HIV Protease Inhibitors
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
ClinicalTrials.gov processed this data on September 21, 2018
This information is provided by ClinicalTrials.gov.