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

NCT00002382 | Completed Phase 3

• 2 other identifiers: 229LSV14974
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

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

Interventions

Saquinavir DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Hoffmann - La Roche Inc

Nutley, New Jersey, 071101199, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Saquinavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinolines

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1997-06

Locations

US (1)