HIV InfectionsPhase 1NCT00002111
A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.
A Phase 1 study testing Saquinavir in people with HIV Infections, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Saquinavir
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Univ School of Medicine
Stanford, California, 943055107
About this study
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Saquinavir
- Keywords
- AIDS-Related Complex, Saquinavir, HIV Protease Inhibitors
- Medical subject headings
- HIV Infections, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaquinavirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002111
- Sponsor's protocol ID
- 212A
- Other IDs
- EV 14757
- Status last verified
- May 1995
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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. doi: 10.7326/0003-4819-124-12-199606150-00003.
PubMed 8633817
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.
- ClinicalTrials.gov ID
- NCT00002111
- Acronym / sponsor ID
- 212A
- Conditions
- HIV Infections
- Keywords
- AIDS-Related Complex, Saquinavir, HIV Protease Inhibitors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saquinavir | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 8633817Schapiro 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. doi: 10.7326/0003-4819-124-12-199606150-00003.
Related trials for HIV Infections
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
RecruitingObservational study
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
HIV
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
Active, not recruitingPhase 2
A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)
HIV Infections
Active, not recruitingPhase 3
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
HIV Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Saquinavir in people with HIV Infections, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005; AzTrials last refreshed its copy on 6 Nov 2026.