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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002111 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.
Official Title ^ICMJE	A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.
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.
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 Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Endpoint Classification: Pharmacokinetics Study Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Saquinavir
Study Arms / Comparison Groups
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	32
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002111
Responsible Party
Study ID Numbers ^ICMJE	212A, EV 14757
Study Sponsor ^ICMJE	Stanford University
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	May 1995
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP