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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00005118
First received: April 7, 2000
Last updated: June 23, 2005
Last verified: July 2001

April 7, 2000
June 23, 2005
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Complete list of historical versions of study NCT00005118 on ClinicalTrials.gov Archive Site
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The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Indinavir sulfate
  • Drug: Ritonavir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005118
246V, CRX481, 107-00
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Merck Sharp & Dohme Corp.
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NIH AIDS Clinical Trials Information Service
July 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP