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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: Saquinavir	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	4000 participants
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

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	13 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

United States, New Jersey
Hoffmann - La Roche Inc
Nutley, New Jersey, United States, 071101199

Sponsors and Collaborators

Hoffmann-La Roche

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00002382 History of Changes
Other Study ID Numbers:	229L; SV14974
First Posted:	August 31, 2001
Last Update Posted:	June 24, 2005
Last Verified:	June 1997

Keywords provided by NIH AIDS Clinical Trials Information Service:

Zalcitabine; Didanosine; Drug Therapy, Combination; Zidovudine	HIV Protease Inhibitors; Saquinavir; Patient Selection; Anti-HIV Agents

Additional relevant MeSH terms:

Infection; HIV Infections; Acquired Immunodeficiency Syndrome; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases	Saquinavir; HIV Protease Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors