A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.

• ClinicalTrials.gov Identifier: NCT00002111
• Recruitment Status: Completed
• First Posted: August 31, 2001
• Last Update Posted: June 24, 2005
• Sponsor: Stanford University
• Information provided by: NIH AIDS Clinical Trials Information Service

Study Description

Brief Summary:

To investigate the toxicity, antiviral activity, and pharmacokinetics in HIV-infected patients receiving 16 weeks of oral saquinavir mesylate ( Ro 31-8959 ) at one of two doses.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: Saquinavir	Phase 1

Detailed Description:

Cohorts of 16 patients receive 1 of 2 doses of Ro 31-8959 for 20 weeks. Administration of the higher dose will proceed only after 2-week safety data for the first eight patients on the lower dose has been reviewed.

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 32 participants
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria

Patients must have:

• Documented HIV infection.
• CD4 count 200 - 500 cells/mm3.
• No evidence of viral resistance.
• HIV RNA quantifiable by PCR.
• Negativity for HBsAg, HBeAg, and anti-HBc.

NOTE:

• Fifty percent of patients must have measurable p24 antigen levels (> 31 pg/ml).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Active opportunistic infection requiring immediate treatment, such as tuberculosis, cytomegalovirus, cerebral toxoplasmosis, and Pneumocystis carinii pneumonia.
• Unable to maintain adequate oral intake.
• Clinically significant vomiting and/or diarrhea.
• Malignancy, visceral Kaposi's sarcoma, or lymphoma that will require systemic chemotherapy within the next 12 months.
• Unable to comply with protocol requirements, in the judgment of the investigator.
• Any grade 3 or worse laboratory or clinical abnormality.

Concurrent Medication:

Excluded:

• Antineoplastic agents.
• Concomitant or maintenance treatment with excluded experimental drugs and drugs with known nephrotoxic or hepatotoxic potential.

Concurrent Treatment:

Excluded:

• Radiation therapy other than local skin radiation therapy.

Patients with the following prior conditions are excluded:

• Unexplained temperature >= 38.5 C (101.5 F) persisting for 14 days or more within a 30-day period.
• Unexplained, chronic diarrhea persisting for 14 days or more within a 30-day period.

Prior Medication:

Excluded:

• Prior treatment with an HIV proteinase inhibitor.
• AZT within 30 days prior to study entry OR lasting more than 1 year.
• Other antiretroviral therapy (besides AZT) within 30 days prior to study entry OR lasting more than 14 days.
• Acute therapy for an opportunistic infection within 14 days prior to study entry.

Contacts and Locations

Locations

United States, California

Stanford Univ School of Medicine

Stanford, California, United States, 943055107

Sponsors and Collaborators

Stanford University

More Information

Publications:

Schapiro JM, Winters MA, Stewart F, Efron B, Norris J, Kozal MJ, Merigan TC. The effect of high-dose saquinavir on viral load and CD4+ T-cell counts in HIV-infected patients. Ann Intern Med. 1996 Jun 15;124(12):1039-50. doi: 10.7326/0003-4819-124-12-199606150-00003.

• ClinicalTrials.gov Identifier: NCT00002111
• Other Study ID Numbers: 212A; EV 14757
• First Posted: August 31, 2001
• Last Update Posted: June 24, 2005
• Last Verified: May 1995

Keywords provided by NIH AIDS Clinical Trials Information Service:

AIDS-Related Complex; Saquinavir; HIV Protease Inhibitors

Additional relevant MeSH terms:

HIV Infections; Acquired Immunodeficiency Syndrome; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Saquinavir; HIV Protease Inhibitors; Viral 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