NCT00002236

Brief Summary

The purpose of this study is to see whether it is better to take delavirdine (DLV) plus indinavir (IDV) plus zidovudine (ZDV) twice a day or three times a day.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for not_applicable hiv-infections

Geographic Reach
1 country

6 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

April 1, 2000

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationZidovudineDrug Administration ScheduleHIV Protease InhibitorsCD4 Lymphocyte CountIndinavirDelavirdineReverse Transcriptase InhibitorsAnti-HIV AgentsViral Load

Interventions

Indinavir sulfateDRUG
Delavirdine mesylateDRUG
ZidovudineDRUG

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • You may be eligible for this study if you:
  • Are HIV-positive.
  • Have a viral load (level of HIV in the blood) of at least 20,000 copies/ml.
  • Have a CD4 cell count of at least 50 cells/mm3.
  • Are at least 14 years old (consent of parent or guardian is required if under 18).

You may not qualify if:

  • You will not be eligible for this study if you:
  • Have ever taken an anti-HIV drug other than ZDV.
  • Have taken ZDV for more than 1 month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

AIDS Healthcare Foundation

Los Angeles, California, 90027, United States

Location

UCSF AIDS Research Institute

San Francisco, California, 94105, United States

Location

Saint Luke's - Roosevelt Hosp Ctr

New York, New York, 10019, United States

Location

Anderson Clinical Research

Pittsburgh, Pennsylvania, 15213, United States

Location

Univ of Tennessee / Div of Infect Dis / Dept of Med

Memphis, Tennessee, 38165, United States

Location

Infectious Disease Physicians Inc

Annandale, Virginia, 22203, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

IndinavirDelavirdineZidovudine

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 CompoundsPiperazinesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingThymidinePyrimidine NucleosidesPyrimidinesDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
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: 2000-04

Locations

US(6)