Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir
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ClinicalTrials.gov Identifier: NCT00002220 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by:
NIH AIDS Clinical Trials Information Service
Tracking Information | |||
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First Submitted Date ICMJE | November 2, 1999 | ||
First Posted Date ICMJE | August 31, 2001 | ||
Last Update Posted Date | June 24, 2005 | ||
Study Start Date ICMJE | Not Provided | ||
Primary Completion Date | Not Provided | ||
Current Primary Outcome Measures ICMJE | Not Provided | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir | ||
Official Title ICMJE | Multi-Center, Open-Label Study of the Effect of Indinavir, Efavirenz, and Adefovir Dipivoxil Combination Therapy in Patients Who Have Failed Nelfinavir | ||
Brief Summary | The purpose of this study is to compare the effectiveness of giving indinavir plus efavirenz plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients who have never taken a protease inhibitor (PI). Effectiveness is measured by the number of patients who have a viral load (level of HIV in the blood) below 400 copies/ml after 48 weeks of treatment. | ||
Detailed Description | In this open-label, nonrandomized study, 120 HIV-infected patients are stratified into two groups: failed nelfinavir vs protease inhibitor-naive. All patients receive indinavir plus efavirenz plus adefovir dipivoxil plus and L-carnitine, orally. Plasma vRNA is measured every 4 weeks until Week 16, then every 8 weeks for the remainder of the 48-week study. | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 3 | ||
Study Design ICMJE | Primary Purpose: Treatment | ||
Condition ICMJE | HIV Infections | ||
Intervention ICMJE |
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Study Arms | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Enrollment ICMJE |
120 | ||
Original Enrollment ICMJE | Same as current | ||
Study Completion Date | Not Provided | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria ICMJE | Inclusion Criteria Patients must have:
Nelfinavir-Failure Group:
Control Group:
Exclusion Criteria Prior Medication: Excluded: Control group:
Required: Nelfinavir-failure patients:
Control group:
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Sex/Gender |
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Ages | 16 Years and older (Child, Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00002220 | ||
Other Study ID Numbers ICMJE | 246N 075-00 |
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Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | NIH AIDS Clinical Trials Information Service | ||
Verification Date | June 1999 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |