NCT00002416

Brief Summary

The purpose of this study is to compare two anti-HIV drugs, FTC and lamivudine (3TC), when given with either stavudine (d4T) or zidovudine (ZDV) and one other anti-HIV drug.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
390

participants targeted

Target at P50-P75 for phase_3 hiv-infections

Geographic Reach
1 country

2 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

March 1, 2000

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

HIV-1ZalcitabineZidovudineStavudineHIV Protease InhibitorsLamivudineRNA, ViralReverse Transcriptase InhibitorsAnti-HIV Agents

Interventions

EmtricitabineDRUG
LamivudineDRUG

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 at least 18 years old.
  • Are HIV-positive.
  • Have a viral load below 400 copies/ml.
  • Agree to use a barrier method of birth control (such as condoms) during the study.
  • Have taken one of the following anti-HIV drug combinations: (1) 3TC plus d4T or ZDV plus a protease inhibitor (PI) for at least 8 weeks, or (2) 3TC plus d4T or ZDV plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) for at least 12 weeks. (You must show the date you started on this combination.)

You may not qualify if:

  • You will not be eligible for this study if you:
  • Have had severe diarrhea or have been unable to eat as much as you need due to nausea, vomiting, or stomachache within 30 days of study entry.
  • Have had a serious medical event within 30 days prior to study entry.
  • Are taking hydroxyurea.
  • Have Grade 2 or higher peripheral neuropathy.
  • Abuse alcohol or drugs.
  • Are pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dr Robert Wallace

St. Petersburg, Florida, 33713, United States

Location

North Shore Univ Hosp

Great Neck, New York, 11021, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

EmtricitabineLamivudine

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)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesZalcitabineDideoxynucleosides

Study Officials

  • Charles van der Horst

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
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: 2000-03

Locations

US(2)