A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002111|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Saquinavir||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||32 participants|
|Masking:||None (Open Label)|
|Official Title:||A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.|
Choosing 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, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|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).
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.
- 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.
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 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002111
|United States, California|
|Stanford Univ School of Medicine|
|Stanford, California, United States, 943055107|
|Other Study ID Numbers:||
|First Posted:||August 31, 2001 Key Record Dates|
|Last Update Posted:||June 24, 2005|
|Last Verified:||May 1995|
HIV Protease Inhibitors
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Viral Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors