NCT00541463

Brief Summary

A study comparing Indinavir plus Ritonavir plus 2 NRTIs vs. Nelfinavir 1250 plus two nucleoside reverse transcriptase inhibitors (NRTIs) in the treatment of HIV positive patients who have not responded to or are intolerant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) containing treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for phase_2 hiv-infections

Timeline
Completed

Started Jan 2001

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

January 1, 2001

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

First QC Date

October 9, 2007

Last Update Submit

February 16, 2017

Conditions

HIV Infections

Keywords

HIVTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Plasma viral RNA levels will be measured at predetermined time points to determine mean change

Secondary Outcomes (1)

  • CD4 cell counts will be measured at predetermined time points to determine change from baseline

Interventions

MK0639, indinavir sulfate / Duration of Treatment: 48 WeeksDRUG
Comparator: nelfinavir mesylate / Duration of Treatment: 48 WeeksDRUG

Eligibility Criteria

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

You may qualify if:

  • At least 18 years of age
  • HIV positive
  • No active heart disease

You may not qualify if:

  • Pregnant or breast feeding
  • Unwilling to use birth control or abstinence to prevent pregnancy
  • Received an investigational drug or vaccine within the past 30 days or is planning to receive other investigational study drug/vaccine or interferon while in the study
  • Plan to receive NNRTIs while in the study
  • Received therapy which lowers body's ability to fight infection within the past 30 days or while in the study
  • Alcohol or substance abuse
  • Hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV Infections

Interventions

IndinavirDuration of Therapy

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 CompoundsPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2007

First Posted

October 10, 2007

Study Start

January 1, 2001

Study Completion

May 1, 2003

Last Updated

February 17, 2017

Record last verified: 2017-02