NCT00002383

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 1997

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug Administration ScheduleHIV Protease InhibitorsDosage FormsSaquinavirAnti-HIV Agents

Interventions

SaquinavirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have:
  • CD4 count of 100 to 500 cells/mm3.
  • Greater than 20,000 HIV-RNA copies/ml.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Univ of Alabama at Birmingham / 1917 Rsch Cln

Birmingham, Alabama, 35294, United States

Location

Davis Med Ctr

San Francisco, California, 94114, United States

Location

Mt Zion Hosp of UCSF / HIV Research Ctr

San Francisco, California, 94115, United States

Location

Pacific Oaks Med Group / Research & Scientific Investiga

Sherman Oaks, California, 91403, United States

Location

Tulane Univ Med Ctr / Infectious Diseases Sect

New Orleans, Louisiana, 70112, United States

Location

New England Med Ctr

Boston, Massachusetts, 02111, United States

Location

Kansas City AIDS Research Consortium

Kansas City, Missouri, 64108, United States

Location

Harkness Pavilion

New York, New York, 10032, United States

Location

Oregon Health Sciences Univ

Portland, Oregon, 97201, United States

Location

Univ of Texas Med Branch / Virology Clinic

Galveston, Texas, 775550882, United States

Location

Related Publications (1)

  • Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8.

    PMID: 11364377BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Saquinavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinolines

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1997-07

Locations

US(10)