NCT00002448

Brief Summary

The purpose of this study is to examine how the immune systems of HIV-infected patients react to 2 anti-HIV drug combinations.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3 hiv-infections

Geographic Reach
1 country

3 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

HIV Infections

Keywords

Drug Therapy, CombinationHIV Protease InhibitorsRitonavirDosage FormsSaquinavirReverse Transcriptase InhibitorsAnti-HIV Agentsefavirenz

Interventions

RitonavirDRUG
EfavirenzDRUG
SaquinavirDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (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 greater than 75 cells/mm3.
  • Are at least 16 (need consent of parent or guardian if under 18).
  • Are able to complete the study.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UCLA Care Ctr

Los Angeles, California, 900951793, United States

Location

Palo Alto Veterans Affairs Health Care System

Palo Alto, California, 94304, United States

Location

Robert Wood Johnson Med School/UMDNJ

New Brunswick, New Jersey, 089030019, United States

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

  • Mark Holodniy

    PRINCIPAL INVESTIGATOR

  • Joseph John

    STUDY CHAIR

  • Ronald Mitsuyasu

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Intervention Model
PARALLEL
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

US(3)