A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002111
- Run by
- Stanford University
- People needed
- 32
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Stanford Univ School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
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