NCT00002374

Brief 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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at below P25 for phase_3 hiv-infections

Geographic Reach
1 country

7 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

August 1, 1997

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

HIV-1Drug Therapy, CombinationAcquired Immunodeficiency SyndromeHIV Protease InhibitorsRNA, ViralSaquinavirAnti-HIV AgentsViral Load

Interventions

RitonavirDRUG
Nelfinavir mesylateDRUG
SaquinavirDRUG
StavudineDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Pacific Oaks Med Ctr

Beverly Hills, California, 90211, United States

Location

Tower Infectious Diseases / Med Associates Inc

Los Angeles, California, 90048, United States

Location

Community Research Initiative of South Florida

Coral Gables, Florida, 33146, United States

Location

Ctr for Quality Care

Tampa, Florida, 33609, United States

Location

Community Research Initiative of New England

Brookline, Massachusetts, 02445, United States

Location

AIDS Ctr

New York, New York, 10011, United States

Location

Anderson Clinical Research / Inc

Pittsburgh, Pennsylvania, 15213, 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 InfectionsAcquired Immunodeficiency Syndrome

Interventions

RitonavirNelfinavirSaquinavirStavudine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingQuinolinesThymidinePyrimidine NucleosidesPyrimidinesDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 3
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: 1997-08

Locations

US(7)