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

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: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Saquinavir Saquinavir mesylate

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:


Estimated 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


Ages Eligible for Study:	13 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
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

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


ClinicalTrials.gov Identifier:	NCT00002382 History of Changes
Other Study ID Numbers:	229L SV14974
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 29, 2016