NCT00002234

Brief Summary

The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2 hiv-infections

Geographic Reach
1 country

5 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

August 30, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

November 1, 2004

First QC Date

August 30, 2001

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationReverse Transcriptase InhibitorsAnti-HIV Agents

Interventions

EfavirenzDRUG
Adefovir dipivoxilDRUG
LamivudineDRUG
DidanosineDRUG

Eligibility Criteria

Age13 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.
  • Are at least 13 years old (need consent of parent or guardian if under 18).
  • Have an HIV count of 5,000 copies/ml or more within 30 days prior to study entry.
  • Have a CD4+ count of 50 cells/mm3 or more.

You may not qualify if:

  • You will not be eligible for this study if you:
  • Are diagnosed with hepatitis within 30 days prior to study entry.
  • Have certain serious medical conditions, including an AIDS-defining clinical condition.
  • Received chemotherapy or radiation therapy within 30 days of study entry.
  • Have taken any nucleoside reverse transcriptase inhibitors (NRTIs) for more than 2 weeks.
  • Have ever taken 3TC.
  • Have ever taken any non-nucleoside reverse transcriptase inhibitors (NNRTIs).
  • Have taken medications that affect your immune system within 30 days prior to study entry.
  • Have received a vaccine within 30 days prior to study entry.
  • Are enrolled in another anti-HIV drug study while participating in this study.
  • Abuse alcohol or drugs.
  • Are pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pacific Oaks Med Group

Beverly Hills, California, 90211, United States

Location

Univ of Colorado / Health Science Ctr

Denver, Colorado, 80262, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30308, United States

Location

Brown Univ School of Medicine

Providence, Rhode Island, 02908, United States

Location

Hampton Roads Med Specialists

Hampton, Virginia, 23666, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

efavirenzadefovir dipivoxilLamivudineDidanosine

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)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesInosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingRibonucleosides

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2001

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 2004-11

Locations

US(5)