A Study of Indinavir Plus Ritonavir Plus Two NRTIs vs. Nelfinavir Plus Two NRTIs in HIV Positive Patients (0639-112)(COMPLETED)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party)
Merck Sharp & Dohme Corp.
First received: October 9, 2007
Last updated: February 16, 2017
Last Verified: February 2017
History of Changes
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.
Drug : MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks
Drug : Comparator: nelfinavir mesylate / Duration of Treatment: 48 Weeks
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
- CD4 cell counts will be measured at predetermined time points to determine change from baseline
|Study Start Date:||January 2001|
|Study Completion Date:||May 2003|
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- At least 18 years of age
- HIV positive
- No active heart disease
- 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
Contacts and LocationsChoosing 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 CollaboratorsMerck Sharp & Dohme Corp.
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|
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|
|Study First Received:||October 9, 2007|
|Last Updated:||February 16, 2017|
Keywords provided by Merck Sharp & Dohme Corp.:HIV
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.