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A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease. Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease. conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease. Clinical research trials and A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease. medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.. A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease. Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease. clinical trial. Participants oftentimes recieve the finest healthcare available for their A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease. condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.  A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.
A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.
For Condition: HIV Infections
Status: Completed
Sponsor(s): Stanford University ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 32
Location and Contact Information:
Stanford Univ School of Medicine
Stanford, California, 943055107
United States
Additional Information:
Study ID Numbers: 212A; EV 14757
Study Start Date:
Record last reviewed: May 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002111
Other Hiv Infections Studies:
1. A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination with Anti-HIV Therapy (HAART) in HIV-Positive Patients
2. Effect of a T-20 Based Anti-HIV Drug Regimen on HIV Reservoirs
3. A Study of 1592U89 in HIV-Infected Adults
4. A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of the Therion Recombinant Vaccinia-HIV-1 IIIB ENV/GAG/POL Vaccine (TCB-3B) and MN RGP 120/HIV-1 In Alum.
5. Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Stanford Clinical Trials
A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.
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