HIV InfectionsPhase 4NCT00002425
The Safety and Effectiveness of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs
A Phase 4 study testing Saquinavir in people with HIV Infections, run by Hoffmann-La Roche at 1 site in United States.
Trial summary
To evaluate the safety and antiretroviral activity of saquinavir soft gelatin capsule formulation (SQV-SGC) in combination with other antiretroviral drugs. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Saquinavir
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 4
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Antiretroviral treatments other than PIs.
- Patients must have:
- HIV infection.
- No prior experience with PIs. (Note:
- At least 75 percent of patients must be naive to PIs.)
Who cannot join
- Concurrent Medication:
- Excluded:
- PIs other than SQV.
- Prior Medication:
- Excluded:
- Any PIs (see note in General Criteria--Inclusion).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open-Label Study of the Safety and Activity of Saquinavir Soft Gelatin Capsule Formulation (Saquinavir SGC) in Combination With Other Antiretroviral Drugs
To evaluate the safety and antiretroviral activity of saquinavir soft gelatin capsule formulation (SQV-SGC) in combination with other antiretroviral drugs.
Read the detailed description
All patients receive SQV as monotherapy or in combination with other antiretroviral drugs chosen by the investigator and patient. (This study provides only SQV.) Patients may not choose another protease inhibitor (PI) as part of their combination therapy; furthermore, patients taking PIs other than SQV must undergo a 5-day washout period before study-drug administration. Patients are monitored for adverse events and changes in routine laboratory tests, plasma viral load, and CD4+ T cell levels. Outcomes are analyzed by stratifying patients according to CD4+ T cell levels and prior history with protease inhibitors.
- Conditions
- HIV Infections
- Being tested
- Saquinavir
- Keywords
- Drug Therapy, Combination, Saquinavir, HIV Protease Inhibitors, Dosage Forms, Anti-HIV Agents
- Medical subject headings
- HIV Infections
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.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 4
- Primary purpose
- Treatment
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002425
- Sponsor's protocol ID
- 229E
- Other IDs
- NV15182B
- Status last verified
- Dec 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No