HIV InfectionsPhase 1NCT00002383
A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients
A Phase 1 study testing Saquinavir in people with HIV Infections, run by Hoffmann-La Roche at 10 sites in United States.
Trial summary
To compare the antiviral activity, safety, and pharmacokinetics of saquinavir hard gel capsule (HGC) formulation, to 1 of 3 doses of saquinavir soft gel capsule (SGC) formulation administered orally every 8 hours for 4 weeks. 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
- 80 participants
- Where
- 10 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
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:
- CD4 count of 100 to 500 cells/mm3.
- Greater than 20,000 HIV-RNA copies/ml.
Who cannot join
- Prior Medication:
- Excluded:
- Prior treatment with protease inhibitors.
- Required:
- Less than 8 weeks prior antiretroviral treatment (For at least 25% of patients).
- At least 8 weeks prior antiretroviral treatment (For at least 25% of patients).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Univ of Alabama at Birmingham / 1917 Rsch Cln
Birmingham, Alabama, 35294
New England Med Ctr
Boston, Massachusetts, 02111
Univ of Texas Med Branch / Virology Clinic
Galveston, Texas, 775550882
Kansas City AIDS Research Consortium
Kansas City, Missouri, 64108
Tulane Univ Med Ctr / Infectious Diseases Sect
New Orleans, Louisiana, 70112
Harkness Pavilion
New York, New York, 10032
Oregon Health Sciences Univ
Portland, Oregon, 97201
Davis Med Ctr
San Francisco, California, 94114
Mt Zion Hosp of UCSF / HIV Research Ctr
San Francisco, California, 94115
Pacific Oaks Med Group / Research & Scientific Investiga
Sherman Oaks, California, 91403
About this study
Official title: A Randomized, Parallel, Open-Label Study Comparing Saquinavir (Hard Gelatin Formulation, 600 Mg Tid) to Saquinavir Soft Gelatin Formulation [(400 Mg, 800 Mg, 1200 Mg) Tid} x 4 Weeks in HIV Infected Patients
To compare the antiviral activity, safety, and pharmacokinetics of saquinavir hard gel capsule (HGC) formulation, to 1 of 3 doses of saquinavir soft gel capsule (SGC) formulation administered orally every 8 hours for 4 weeks.
Read the detailed description
Patients are randomly assigned to one of the four treatment groups as follows:
Group 1: 10 patients receive saquinavir HGC. Group 2: 10 patients receive saquinavir SGC. Group 3: 30 patients receive saquinavir SGC at an intermediate dose. Group 4: 30 patients receive saquinavir SGC at the highest study dose. Upon completion of the initial 4 weeks, all patients may have the option to continue their originally-assigned therapy as monotherapy unless significant drug toxicity intervenes. If the analysis of the initial 4 week data identifies an optimal dose of saquinavir SGC, patients may have the option to change to this optimal dose in a treatment extension phase of the protocol. Patients in this extension phase may choose to remain on monotherapy unless they experience significant drug toxicity, their CD4 count or HIV-RNA levels return to baseline, until saquinavir is approved by the FDA or study termination, whichever comes first.
NOTE: A washout >= 28 days is required for patients on antiretroviral therapy.
- Conditions
- HIV Infections
- Being tested
- Saquinavir
- Keywords
- Drug Administration Schedule, HIV Protease Inhibitors, Dosage Forms, Saquinavir, 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.
- 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 1
- Primary purpose
- Treatment
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002383
- Sponsor's protocol ID
- 229M
- Other IDs
- NV15107
- Status last verified
- Jul 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