A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: May 1995
History of Changes
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.
Drug : Saquinavir
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.|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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.Eligibility
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- Fifty percent of patients must have measurable p24 antigen levels (> 31 pg/ml).
- 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.
- Antineoplastic agents.
- Concomitant or maintenance treatment with excluded experimental drugs and drugs with known nephrotoxic or hepatotoxic potential.
- Radiation therapy other than local skin radiation therapy.
- 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 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.
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
Contacts and LocationsChoosing 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: NCT00002111
Locations Show More
|United States, California|
|Stanford Univ School of Medicine|
|Stanford, California, United States, 943055107|
Sponsors and CollaboratorsStanford University
|Responsible Party:||Stanford University|
|ClinicalTrials.gov Identifier:||NCT00002111 History of Changes|
|Other Study ID Numbers:||212A|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:AIDS-Related Complex
HIV Protease Inhibitors
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
ClinicalTrials.gov processed this data on June 01, 2020
This information is provided by ClinicalTrials.gov.