HIV InfectionsPhase 4NCT00002229
Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients
A Phase 4 study testing Saquinavir in people with HIV Infections, run by Hoffmann-La Roche at 22 sites in 3 countries.
Trial summary
The purpose of this study is to see if it is safe and effective to give saquinavir (as a soft gel capsule taken by mouth) along with 2 other anti-HIV drugs to HIV-infected patients. Read more about this study
- Who is it for?
- Ages 16 to 64 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Saquinavir
- How many people
- 80 participants
- Where
- 22 sitesin 3 countries
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 16 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- You may be eligible for this study if you:
- Are HIV-positive.
- Have an HIV count of 5,000 copies/ml or more.
- Have a CD4 count of 100 cells/mm3 or more.
- Meet specific requirements if you have ever taken NRTIs.
- Are 16 - 64 years old (need consent if under 18).
- Agree to use effective methods of birth control during the study.
Who cannot join
- You will not be eligible for this study if you:
- Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 2 weeks.
- Have taken all the available NRTIs.
- Have certain serious medical conditions, including severe liver disease or active opportunistic (AIDS-related) infection.
- Have a history of weight loss, muscle pain, and loss of appetite.
- Have taken certain medications, including anti-HIV drugs other than those required by this study.
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- Are pregnant or breast-feeding.
- Abuse alcohol or drugs.
- Are unable to complete the study for any reason.
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
United States20 sites
SUNY Health Sciences Ctr
Brooklyn, New York, 11203
Brookdale Univ Med Ctr
Brooklyn, New York, 11212
Univ of Virginia Health Sciences Ctr
Charlottesville, Virginia, 22908
Univ of Illinois Hosp at Chicago
Chicago, Illinois, 60612
NTouch Research Corp
Decatur, Georgia, 30033
ASC Inc
Hobson City, Alabama, 36201
Diversified Med Practices, PA
Houston, Texas, 77027
Duval County Health Department
Jacksonville, Florida, 32206
Univ of Kentucky
Lexington, Kentucky, 40536
Mt Vernon Hosp
Mount Vernon, New York, 10550
C100 HIV Outpatient Program
New Orleans, Louisiana, 70112
Mount Sinai Med Ctr
New York, New York, 100296574
Harlem Hosp Infectious Disease
New York, New York, 10037
NJ CRI
Newark, New Jersey, 07103
UMDNJ / Dept of Ob/Gyn
Newark, New Jersey, 07103
Wilbert Jordan
Paramount, California, 90723
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, 02860
Dean Martin
Phoenix, Arizona, 85006
Ctr for Quality Care
Tampa, Florida, 33609
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009
Canada1 site
Univ of British Columbia Oak Tree Clinic
Vancouver, British Columbia
About this study
Official title: A Phase IV, Non-Comparative Study to Evaluate FORTOVASE (Saquinavir) Soft Gel Capsule (SGC) TID Regimen in Combination With Two NRTI's in HIV-1 Infected Women and Men
The purpose of this study is to see if it is safe and effective to give saquinavir (as a soft gel capsule taken by mouth) along with 2 other anti-HIV drugs to HIV-infected patients.
Read the detailed description
Prior to initiation of study treatment all patients are screened and baseline lab values are taken. Patients then receive the study treatment, FORTOVASE, two times a day plus 2 new NRTI's. Assessments will be performed at specified intervals throughout the duration of treatment.
- Conditions
- HIV Infections
- Being tested
- Saquinavir
- Keywords
- Drug Therapy, Combination, HIV Protease Inhibitors, Dosage Forms, Saquinavir, Reverse Transcriptase Inhibitors, 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
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- S Palleja, Study chairC Karol, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002229
- Sponsor's protocol ID
- 229Q
- Other IDs
- NR15750
- Status last verified
- Dec 1999
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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 Phase IV, Non-Comparative Study to Evaluate FORTOVASE (Saquinavir) Soft Gel Capsule (SGC) TID Regimen in Combination With Two NRTI's in HIV-1 Infected Women and Men
- ClinicalTrials.gov ID
- NCT00002229
- Acronym / sponsor ID
- 229Q
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, HIV Protease Inhibitors, Dosage Forms, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- 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.
The purpose of this study is to see if it is safe and effective to give saquinavir (as a soft gel capsule taken by mouth) along with 2 other anti-HIV drugs to HIV-infected patients.
Detailed description
Prior to initiation of study treatment all patients are screened and baseline lab values are taken. Patients then receive the study treatment, FORTOVASE, two times a day plus 2 new NRTI's. Assessments will be performed at specified intervals throughout the duration of treatment.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Are HIV-positive.
- Have an HIV count of 5,000 copies/ml or more.
- Have a CD4 count of 100 cells/mm3 or more.
- Meet specific requirements if you have ever taken NRTIs.
- Are 16 - 64 years old (need consent if under 18).
Key exclusion criteria (9 listed)
- Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 2 weeks.
- Have taken all the available NRTIs.
- Have certain serious medical conditions, including severe liver disease or active opportunistic (AIDS-related) infection.
- Have a history of weight loss, muscle pain, and loss of appetite.
- Have taken certain medications, including anti-HIV drugs other than those required by this study.
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.
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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.
S Palleja study chair
C Karol study chair
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saquinavir in people with HIV Infections, run by Hoffmann-La Roche at 22 sites in 3 countries.
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 7 inclusion and 9 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 22 sites in United States, Canada, Puerto Rico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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.