The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment - Tabular View

Tracking Information
First Received Date ^ICMJE	April 7, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00005118 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment
Official Title ^ICMJE	A Multicenter, Open-Label, 24-Week Study to Evaluate the Efficacy and Safety of Indinavir Sulfate 800 Mg and Ritonavir 200 Mg b.i.d. Plus 2 NRTIs b.i.d. in HIV-1 Infected Individuals Who Require Early Treatment Intervention
Brief Summary	The purpose of this study is to see if it is safe and effective to give indinavir plus ritonavir plus 2 NRTIs to HIV-infected patients who need early intervention treatment.
Detailed Description	Patients receive indinavir bid plus ritonavir bid, plus 2 NRTIs bid (2 new NRTIs or 1 new NRTI and 1 NRTI without evidence of resistance). CD4 cell counts and plasma viral RNA are measured every 4 weeks for the duration of the study. Physical examination and laboratory tests of blood and urine are performed every 4 weeks for the duration of the study. Chest x-ray and 12-lead ECG are done prestudy.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Indinavir sulfate Drug: Ritonavir
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	100
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Are 18 years of age or older. Have a CD4 cell count of at least 50 cells/mm3. Have a viral load (level of HIV in the blood) of at least 400 copies/ml but no more than 20,000 copies/ml. Have had an initial response to protease inhibitor therapy with a viral load of less than 400 copies/ml in two consecutive tests at least 1 week apart. Have been on anti-HIV (antiretroviral) treatment including indinavir or nelfinavir for at least 16 weeks. Have had virologic failure (two consecutive viral loads that were greater than or equal to 400 copies/ml and less than or equal to 20,000 copies/ml at least 1 week apart) that is not due to another infection, vaccination, or a temporary stop in treatment. Are naive to at least one of the selected NRTIs.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00005118
Responsible Party
Study ID Numbers ^ICMJE	246V, CRX481, 107-00
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	July 2001
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP