NCT00004585

Brief Summary

The purpose of this study is to see if a certain combination of anti-HIV drugs is safe and effective in HIV-infected patients. The drug combination includes a tablet containing lamivudine and zidovudine (called Combivir) plus abacavir plus efavirenz.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 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

Study Start

First participant enrolled

October 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2000

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

November 1, 2000

First QC Date

February 15, 2000

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationZidovudineLamivudineRNA, ViralReverse Transcriptase InhibitorsAnti-HIV AgentsViral Loadabacavirefavirenz

Interventions

Abacavir sulfate, Lamivudine and ZidovudineDRUG
Lamivudine/ZidovudineDRUG
Abacavir sulfateDRUG
EfavirenzDRUG

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.
  • Have HIV levels of 50,000 copies/ml or more within 21 days prior to starting treatment.
  • Are at least 18 years of age.
  • Are willing to use an effective method of birth control during the study.
  • (This study has been changed. A CD4 cell count of 50/mm3 or more within 21 days prior to starting treatment is no longer required.)

You may not qualify if:

  • Patients will not be eligible for this study if they:
  • Are pregnant.
  • Have AIDS.
  • Cannot take medications by mouth.
  • Have hepatitis and it is active.
  • Are enrolled in other investigational drug studies.
  • Are allergic to any of the study drugs.
  • Have a serious medical condition, such as heart disease.
  • Have ever taken certain anti-HIV drugs such as nonnucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs).
  • Have ever had more than 7 days of treatment with a nucleoside reverse transcriptase inhibitor (NRTI). Patients should have no prior treatment with abacavir and no prior treatment with at least one of the following: lamivudine or zidovudine.
  • Have had radiation therapy or chemotherapy within 4 weeks prior to study entry, or plan to have such therapy during the study.
  • Have received medications that might affect the immune system, such as systemic corticosteroids, interleukins, vaccines, or interferons within 4 weeks prior to study entry.
  • Have received an HIV vaccine within 3 months prior to study entry.
  • Are taking foscarnet, hydroxyurea, or other drugs that work against HIV.
  • Have taken certain medications such as astemizole, cisapride, dihydroergotamine, ergotamine, ganciclovir, interferon-alpha, midazolam, terfenadine, and triazolam within 21 days of study entry.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Tower Infectious Diseases / Med Associates Inc

Los Angeles, California, 90048, United States

Location

George Washington Univ Med Ctr

Washington D.C., District of Columbia, 20037, United States

Location

North Shore Univ Hosp

Manhasset, New York, 11030, United States

Location

Thomas Jefferson Univ

Philadelphia, Pennsylvania, 19107, United States

Location

Dallas Veterans Administration Med Ctr

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

abacavirLamivudineZidovudinelamivudine, zidovudine drug combinationefavirenz

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 NucleosidesDideoxynucleosidesThymidine

Study Design

Study Type
interventional
Phase
phase 4
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 15, 2000

First Posted

August 31, 2001

Study Start

October 1, 1999

Last Updated

June 24, 2005

Record last verified: 2000-11

Locations

US(5)