A Study of Saquinavir Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Saquinavir (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Hoffmann-La Roche
Summary
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.
Clinical Details
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
Study design: Treatment, Open Label
Detailed description:
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.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Hoffmann - La Roche Inc, Nutley, New Jersey 071101199, United States
Additional Information
Last updated: June 23, 2005
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