skip to content

Clinical Trials

MainTitle

A Study of Indinavir Plus Ritonavir Plus Two NRTIs vs. Nelfinavir Plus Two NRTIs in HIV Positive Patients (0639-112)(COMPLETED)

This study has been completed
Sponsor
Merck Sharp & Dohme Corp.


Information provided by (Responsible Party)
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier
NCT00541463

First received: October 9, 2007
Last updated: February 16, 2017
Last Verified: February 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks
Drug : Comparator: nelfinavir mesylate / Duration of Treatment: 48 Weeks
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Randomized, Study to Compare the Efficacy and Safety of Indinavir 800 mg b.i.d. Plus Ritonavir 100 mg b.i.d. Plus Two NRTIs vs. Nelfinavir 1250 mg b.i.d. Plus Two NRTIs in HIV-1 Seropositive Patients Who Have Failed or Are Intolerant to an NNRTI Containing Regimen

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures

  • Plasma viral RNA levels will be measured at predetermined time points to determine mean change
Secondary Outcome Measures:
  • CD4 cell counts will be measured at predetermined time points to determine change from baseline

Enrollment: 330
Study Start Date: January 2001
Study Completion Date: May 2003

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

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


Exclusion Criteria:
  • 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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541463

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information

Additional Information:

Merck: Patient & Caregiver U.S. Product Web Site

Responsible Party: Merck Sharp & Dohme Corp.  
ClinicalTrials.gov Identifier: NCT00541463   History of Changes  
Other Study ID Numbers: 0639-112  
  2007_642  
Study First Received: October 9, 2007  
Last Updated: February 16, 2017  

Keywords provided by Merck Sharp & Dohme Corp.:

HIV
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Ritonavir
Nelfinavir
Indinavir

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.