NCT00002375

Brief Summary

The purpose of this study is to see if it is safe and effective to treat HIV-infected patients with indinavir (IDV) plus nelfinavir (NFV), 2 anti-HIV medications. It is thought that IDV plus NFV will be a safe drug combination for treating HIV.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable 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

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

February 1, 2000

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationHIV Protease InhibitorsIndinavirNelfinavirAnti-HIV Agents

Interventions

Indinavir sulfateDRUG
Nelfinavir mesylateDRUG

Eligibility Criteria

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

You may qualify if:

  • You may be eligible for this study if you:
  • Are HIV-positive.
  • Have a CD4 count of at least 100 cells/mm3.
  • Have a plasma viral load (level of HIV in the blood) of at least 30,000 copies/ml.
  • Are at least 18 years old.

You may not qualify if:

  • You will not be eligible for this study if you:
  • Have ever been treated with any protease inhibitors (PIs).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Univ of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

UCSD Treatment Ctr / Dept of Medicine and Pediatrics

San Diego, California, 92103, United States

Location

Univ of Pittsburgh / Graduate School of Public Health

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

IndinavirNelfinavir

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 CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 2000-02

Locations

US(3)