NCT00002155

Brief Summary

To compare effects on CD4 counts and serum viral RNA among HIV-seropositive, zidovudine (AZT)-experienced patients in three treatment arms: indinavir sulfate ( MK-639; Crixivan ) plus AZT plus lamivudine ( 3TC ) versus MK-639 alone versus AZT/3TC.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

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

June 1, 1996

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationAcquired Immunodeficiency SyndromeAntiviral AgentsZidovudineHIV Protease InhibitorsLamivudineIndinavir

Interventions

Indinavir sulfateDRUG
LamivudineDRUG
ZidovudineDRUG

Eligibility Criteria

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

You may qualify if:

  • Concurrent Medication:
  • Allowed for all patients:
  • Standard prophylaxis for opportunistic infections.
  • Continuation of treatment for opportunistic infection.
  • Allowed for open-label study patients:
  • Rifampin.
  • Patients must have:
  • HIV positivity.
  • CD4 count \<= 50 cells/mm3.
  • More than 6 months of prior AZT (blinded study only).
  • NOTE:
  • Patients on the open-label study must have AZT intolerance or have \< 6 months of prior AZT.
  • Prior Medication:
  • Required for blinded study patients:
  • \> 6 months of prior AZT.
  • +4 more criteria

You may not qualify if:

  • Concurrent Medication:
  • Excluded in all patients:
  • Immunosuppressants.
  • Excluded in blinded study patients:
  • AZT, ddI, ddC, or d4T.
  • Rifampin.
  • Excluded in open-label study patients:
  • TC.
  • Prior Medication:
  • Excluded in all patients:
  • Prior protease inhibitors.
  • Investigational agents and immunomodulators within 30 days prior to study entry.
  • Immunosuppressants within 2 weeks prior to study entry.
  • Excluded in blinded study patients:
  • Any prior 3TC.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merck & Co Inc

Whitehouse Station, New Jersey, 088890100, United States

Location

Related Publications (2)

  • Gulick RM, Mellors JW, Havlir D, Eron JJ, Gonzalez C, McMahon D, Richman DD, Valentine FT, Jonas L, Meibohm A, Emini EA, Chodakewitz JA. Treatment with indinavir, zidovudine, and lamivudine in adults with human immunodeficiency virus infection and prior antiretroviral therapy. N Engl J Med. 1997 Sep 11;337(11):734-9. doi: 10.1056/NEJM199709113371102.

    PMID: 9287228BACKGROUND

  • Hirsch M, Steigbigel R, Staszewski S, Mellors J, Scerpella E, Hirschel B, Lange J, Squires K, Rawlins S, Meibohm A, Leavitt R. A randomized, controlled trial of indinavir, zidovudine, and lamivudine in adults with advanced human immunodeficiency virus type 1 infection and prior antiretroviral therapy. J Infect Dis. 1999 Sep;180(3):659-65. doi: 10.1086/314948.

    PMID: 10438352BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

IndinavirLamivudineZidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidine

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
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: 1996-06

Locations

US(1)