HIV InfectionsPhase 3NCT00002374
A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients
A Phase 3 study testing Ritonavir, Nelfinavir mesylate and Saquinavir in people with HIV Infections, run by Hoffmann-La Roche at 7 sites in United States.
Trial summary
To examine the efficacy of saquinavir SGC (soft gel capsules) in combination with other antiretrovirals in HIV-1 infected patients currently treated with saquinavir HGC (hard gel capsules) measured by the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Ritonavir, Nelfinavir mesylate and Saquinavir
- How many people
- 120 participants
- Where
- 7 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have:
- Documented HIV infection.
- CD4 > 100 cells/mm3.
- Saquinavir HGC-experienced patients (>= 3 months cumulative therapy).
- Required:
- >= 3 months cumulative saquinavir HGC therapy.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Pacific Oaks Med Ctr
Beverly Hills, California, 90211
Community Research Initiative of New England
Brookline, Massachusetts, 02445
Community Research Initiative of South Florida
Coral Gables, Florida, 33146
Tower Infectious Diseases / Med Associates Inc
Los Angeles, California, 90048
AIDS Ctr
New York, New York, 10011
Anderson Clinical Research / Inc
Pittsburgh, Pennsylvania, 15213
Ctr for Quality Care
Tampa, Florida, 33609
About this study
Official title: A Phase IIIB Open-Label Trial Replacing Saquinavir HGC (Ro 31-8959) With Saquinavir SGC (Ro 31-8959) in Combination With Other Antiretroviral Drugs in Patients With HIV-1 Infection
To examine the efficacy of saquinavir SGC (soft gel capsules) in combination with other antiretrovirals in HIV-1 infected patients currently treated with saquinavir HGC (hard gel capsules) measured by the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment.
Read the detailed description
Eligible patients will be stratified by HIV-1 RNA level into 2 populations: 1) >= 5,000-30,000 HIV-1 RNA, 2) > 30,000 HIV-1 RNA. All patients will be randomized to 1 of 3 treatment arms: Arm A - Saquinavir soft gel capsules (SQV SGC) + 2 new nucleoside analogs (reverse transcriptase inhibitors [RTIs]), Arm B - SQV SGC + nelfinavir + stavudine (d4T) or a new RTI, or Arm C - SQV SGC + ritonavir + d4T or a new RTI. All patients will undergo plasma HIV-1 RNA determinations, CD4 lymphocyte counts, hematology and chemistry blood work at baseline, weeks 4, 8, 12, 16 and 24.
- Conditions
- HIV Infections
- Being tested
- Ritonavir, Nelfinavir mesylate, Saquinavir, Stavudine
- Keywords
- HIV-1, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, HIV Protease Inhibitors, RNA, Viral, Saquinavir, Anti-HIV Agents, Viral Load
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitonavirDrug
Nelfinavir mesylateDrug
SaquinavirDrug
StavudineDrug
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 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 3
- Primary purpose
- Treatment
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002374
- Sponsor's protocol ID
- 229G
- Other IDs
- NR15521
- Status last verified
- Aug 1997
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8.
PubMed 11364377