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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Hoffmann-La Roche


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002382

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: June 1997
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV Infections

Drug : Saquinavir
Phase 3

Study Type: Interventional
Study Design: 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:

Enrollment: 4000

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

Eligibility

Ages Eligible for Study: 13 Years and older  
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

Contacts and Locations

Choosing 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

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

Sponsors and Collaborators

Hoffmann-La Roche
More Information

More Information


Responsible Party: Hoffmann-La Roche  
ClinicalTrials.gov Identifier: NCT00002382   History of Changes  
Other Study ID Numbers: 229L  
  SV14974  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

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
Saquinavir

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.