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
Recruitment status was Active, not recruiting
Sponsor:
Merck Sharp & Dohme Corp.
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Ritonavir |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
| Estimated Enrollment: | 100 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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: NCT00005118
Show 40 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005118
Show 40 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
More Information
| ClinicalTrials.gov Identifier: | NCT00005118 History of Changes |
| Other Study ID Numbers: | 246V CRX481 107-00 |
| Study First Received: | April 7, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
HIV-1 Drug Therapy, Combination HIV Protease Inhibitors Ritonavir Indinavir |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load Nelfinavir |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Indinavir Reverse Transcriptase Inhibitors |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on September 27, 2016