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
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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005118
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Hide Study LocationsLocations
| United States, California | |
| Pacific Oaks Research | |
| Beverly Hills, California, United States, 90211 | |
| Ocean View Internal Medicine | |
| Long Beach, California, United States, 90803 | |
| Bisher Akil | |
| Los Angeles, California, United States, 90046 | |
| Tower Infectious Diseases / Med Associates Inc | |
| Los Angeles, California, United States, 90048 | |
| UCSD Med Ctr - Owen Clinic | |
| San Diego, California, United States, 921038681 | |
| San Francisco Veterans Adm Med Cntr | |
| San Francisco, California, United States, 94121 | |
| HIV Institute / Davies Med Ctr | |
| San Francisco, California, United States, 94114 | |
| Avalar Medical Group | |
| Tarzana, California, United States, 91356 | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| United States, Colorado | |
| Benjamin Young | |
| Denver, Colorado, United States, 80220 | |
| United States, Connecticut | |
| University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030 | |
| United States, Florida | |
| IDC Research Initiative | |
| Altamonte Springs, Florida, United States, 32701 | |
| Hillsborough County Health Dept | |
| Tampa, Florida, United States, 33602 | |
| United States, Georgia | |
| Mercer University School of Medicine | |
| Macon, Georgia, United States, 31201 | |
| United States, Idaho | |
| Thomas Coffman MD | |
| Boise, Idaho, United States, 83712 | |
| United States, Illinois | |
| Chicago Ctr for Clinical Research | |
| Chicago, Illinois, United States, 60610 | |
| Northwestern Univ / Infect Dis Div / Pasavant Pav 828 | |
| Chicago, Illinois, United States, 60611 | |
| The CORE Ctr | |
| Chicago, Illinois, United States, 60612 | |
| United States, Kansas | |
| Univ of Kansas School of Medicine | |
| Wichita, Kansas, United States, 67214 | |
| United States, Kentucky | |
| University of Louisville / ID Division | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Tulane Univ School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Institute of Human Virology | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| New England Med Ctr | |
| Boston, Massachusetts, United States, 02111 | |
| United States, New Jersey | |
| Cooper Hospital Early Intervention Program | |
| Camden, New Jersey, United States, 08103 | |
| Dr Ronald Nahass | |
| Somerville, New Jersey, United States, 08876 | |
| United States, New York | |
| Bronx Veterans Affairs Med Ctr | |
| Bronx, New York, United States, 10468 | |
| Mt Vernon Hosp | |
| Mt. Vernon, New York, United States, 10550 | |
| Bellevue Hosp Ctr | |
| New York, New York, United States, 10016 | |
| St Vincents Hosp / Clinical Research Program | |
| New York, New York, United States, 10011 | |
| St Luke Roosevelt Hosp | |
| New York, New York, United States, 10011 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 100296574 | |
| Gramercy Park Physicians LLP | |
| New York, New York, United States, 10003 | |
| SUNY at Stony Brook / Div of Infectious Disease | |
| Stony Brook, New York, United States, 117948153 | |
| United States, North Carolina | |
| Wake Forest Univ School of Medicine | |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, Oklahoma | |
| Oklahoma Univ Health Science Ctr | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Fanno Creek Clinic | |
| Portland, Oregon, United States, 97219 | |
| United States, Pennsylvania | |
| Anderson Clinical Research | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Texas | |
| Univ of Texas Med Branch / Div of Infectious Dis | |
| Galveston, Texas, United States, 775550835 | |
| Thomas Street Clinic | |
| Houston, Texas, United States, 77009 | |
| Univ of Texas Health Sciences Ctr | |
| San Antonio, Texas, United States, 782847838 | |
Sponsors and Collaborators
Merck
More Information
No publications provided
| 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 Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases HIV Protease Inhibitors Indinavir |
Ritonavir Reverse Transcriptase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013