NCT00002443

Brief Summary

To compare the effects on CD4 counts and safety of MK-639 (indinavir, IDV) and AZT administered concomitantly to MK-639 alone and AZT alone in HIV-1 seropositive patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
780

participants targeted

Target at P75+ for not_applicable hiv-infections

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 Completion

Last participant's last visit for all outcomes

January 1, 1996

Completed
3.8 years until next milestone

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

September 1, 1996

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Interventions

Indinavir sulfateDRUG
ZidovudineDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must have:
  • HIV seropositivity.
  • Average CD4 count between 50 and 500 cells/mm3 based on 2 separate pre-study determinations at least 1 week apart.
  • Note:
  • Patients with known hemophilia may be enrolled at the discretion of the investigator.
  • Prior Medication:
  • Excluded:
  • Any protease inhibitor.
  • Significant prior use (greater than 2 weeks) of nucleoside analogues.
  • Chronic therapy for an active opportunistic infection. (Allowed:
  • Prophylaxis with aerosolized pentamidine, trimethoprim/sulfamethoxazole, dapsone, topical antifungals, and isoniazid).
  • Investigational agents or immunomodulators within 30 days prior to study entry.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Acute hepatitis.
  • Lymphoma.
  • Visceral Kaposi's sarcoma.
  • Invasive cervical cancer.
  • Active infection.
  • Concurrent Medication:
  • Excluded:
  • Anticipated immunosuppressive therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV Infections

Interventions

IndinavirZidovudine

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 CompoundsThymidinePyrimidine NucleosidesPyrimidinesDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

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

Study Completion

January 1, 1996

Last Updated

June 24, 2005

Record last verified: 1996-09