NCT00002451

Brief Summary

The purpose of this study is to see if it is safe to give indinavir (IDV) and ritonavir (RTV) in combination with stavudine (d4T) and lamivudine (3TC) to HIV-positive patients who have never received anti-HIV therapy. This study will look at the effectiveness of this drug combination and side effects.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_2 hiv-infections

Geographic Reach
1 country

3 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2000

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 2002

First QC Date

January 17, 2000

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationStavudineHIV Protease InhibitorsCD4 Lymphocyte CountRitonavirLamivudineIndinavirReverse Transcriptase InhibitorsAnti-HIV AgentsViral Load

Interventions

Indinavir sulfateDRUG
RitonavirDRUG
LamivudineDRUG
StavudineDRUG

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.
  • Are at least 18 years old.
  • Have a viral load of 5,000 copies/ml or greater.
  • Have a CD4 count of at least 50 cells/mm3.

You may not qualify if:

  • Patients will not be eligible for this study if they:
  • Have taken any antiretroviral (anti-HIV) agent.
  • Are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Univ of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Albany Med College

Albany, New York, 12208, United States

Location

SUNY at Stony Brook / Division of Infectious Diseases

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

IndinavirRitonavirLamivudineStavudine

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)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzolesZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidine

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 17, 2000

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 2002-07

Locations

US(3)