Trial record 12 of 27 for:
" September 23, 2007":" October 23, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
A Study of Indinavir Plus Ritonavir Plus Two NRTIs vs. Nelfinavir Plus Two NRTIs in HIV Positive Patients
This study has been completed.
Information provided by:
Merck Sharp & Dohme Corp.
First received: October 9, 2007
Last updated: November 5, 2007
Last verified: October 2007
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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
| Study Start Date:
| Study Completion Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
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
Merck Sharp & Dohme Corp.
||Merck Sharp & Dohme Corp.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 9, 2007
||November 5, 2007
||United States: Food and Drug Administration
Keywords provided by Merck Sharp & Dohme Corp.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 26, 2014
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action