A Study of Saquinavir Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Keywords

ClinConnect Summary

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 reser...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• 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.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• • Eligibility for any controlled clinical study of any experimental HIV therapy.
• • Grade 4 hematologic and/or Grade 3 hematologic toxicity at baseline.
• 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.
• • Concomitant therapy and treatment should be kept at a minimum.
• • Current participation in any study formally excluding concomitant treatment with experimental drugs.
• • 1. 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.