NCT00002447

Brief Summary

The purpose of this study is to compare 2 anti-HIV drug combinations.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at below P25 for phase_3 hiv-infections

Geographic Reach
3 countries

26 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

Study Start

First participant enrolled

October 1, 1999

Completed
1 month until next milestone

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

January 1, 2001

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Keywords

Drug Therapy, CombinationSaquinavirHIV Protease InhibitorsRitonavirDosage FormsReverse Transcriptase InhibitorsAnti-HIV Agentsefavirenz

Interventions

Eligibility Criteria

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

You may qualify if:

  • Patients may be eligible for this study if they:
  • Are HIV-positive.
  • Have a viral load of at least 5,000 copies/ml and a CD4 cell count of at least 75 cells/mm3.
  • Are at least 18.
  • Are able to complete the study.

You may not qualify if:

  • Patients will not be eligible for this study if they:
  • Have taken any anti-HIV medications for more than 2 weeks.
  • Are pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Univ of Alabama at Birmingham / AIDS Outpatient Clinic

Birmingham, Alabama, 35294, United States

Location

St Mary's Med Ctr

Long Beach, California, 90813, United States

Location

UCSF - San Francisco Gen Hosp

San Francisco, California, 94110, United States

Location

Kaiser Foundation Hospital

San Francisco, California, 94118, United States

Location

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, 20007, United States

Location

Physicans Home Service

Washington D.C., District of Columbia, 20037, United States

Location

Associates in Research

Fort Myers, Florida, 33901, United States

Location

Univ of Miami / Jackson Memorial Hosp

Miami, Florida, 33136, United States

Location

Illinois Masonic Med Ctr

Chicago, Illinois, 606575147, United States

Location

Saint Michael's Med Ctr / Dept of Infectious Diseases

Newark, New Jersey, 07102, United States

Location

Infectious Disease Specialists of NJ

Union, New Jersey, 07083, United States

Location

Elmhurst Hosp

Elmhurst, New York, 11373, United States

Location

Queens Hospital Center

Jamaica, New York, 11432, United States

Location

LIJMC

New Hyde Park, New York, 11040, United States

Location

East Carolina Univ School of Medicine

Greenville, North Carolina, 27858, United States

Location

Lehigh Valley Hosp

Allentown, Pennsylvania, 18105, United States

Location

Burnside Clinic

Columbia, South Carolina, 29206, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Nicholas Bellos

Dallas, Texas, 75246, United States

Location

Joseph Gathe

Houston, Texas, 77004, United States

Location

Univ of Utah

Salt Lake City, Utah, 84132, United States

Location

Univ of Washington / AIDS Clinical Trial Unit

Seattle, Washington, 98104, United States

Location

Saint Paul's Hosp

Vancouver, British Columbia, Canada

Location

Toronto Gen Hosp

Toronto, Ontario, Canada

Location

Centre Hospitalier de la Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Location

Ponce Univ Hosp

Ponce, 00731, Puerto Rico

Location

MeSH Terms

Conditions

HIV Infections

Interventions

RitonavirefavirenzSaquinavir

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)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingQuinolines

Study Officials

  • JSG Montaner

    PRINCIPAL INVESTIGATOR
  • Ann Collier

    STUDY CHAIR
  • Danielle Rouleau

    STUDY CHAIR
  • Michael Saag

    STUDY CHAIR
  • Paul Volberding

    STUDY CHAIR
  • Sharon Walmsley

    STUDY CHAIR
  • Nicholas Bellos

    STUDY CHAIR
  • Alfred Burnside

    STUDY CHAIR
  • Stephen Follansbee

    STUDY CHAIR
  • Joseph Gathe

    STUDY CHAIR
  • Bruce Hathaway

    STUDY CHAIR
  • Margaret Hoffman-Terry

    STUDY CHAIR
  • Jazila Mantis

    STUDY CHAIR
  • Joseph Masci

    STUDY CHAIR
  • Mahmoud Mustafa

    STUDY CHAIR
  • John Schrank

    STUDY CHAIR
  • Malte Schutz

    STUDY CHAIR
  • Leon Smith

    STUDY CHAIR

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

Study Start

October 1, 1999

Last Updated

June 24, 2005

Record last verified: 2001-01

Locations