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| Sponsor: | Merck |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002406 |
Purpose
The purpose of this study is to determine if two dose levels of indinavir combined with two nucleoside analogue reverse transcriptase inhibitors (NRTIs) have the same effect on plasma viral load (level of HIV in the blood).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Safety Study |
| Official Title: | A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulphate, 800 Mg q 8h Versus 1,200 Mg q 12h in HIV-Infected Individuals Having Plasma Viral RNA Less Than 400 Copies/Ml, on Concomitant Therapy With 2 Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTI) |
| Estimated Enrollment: | 350 |
In this open-label study 350 seropositive HIV-1 men and women are first stratified according to baseline plasma viral RNA (less than 400 copies/mL vs negative plasma viral RNA result) then randomized into one of two arms:
Arm 1: Indinavir (800 mg, q8h) plus two pre-existing NRTIs. Arm 2: Indinavir (1,200 mg, q12h) plus two pre-existing NRTIs. Plasma viral RNA will be measured every 4 weeks for the duration of the 24-week study.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| 1917 Research Clinic | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Ctr for AIDS Research / Education and Service (CARES) | |
| Sacramento, California, United States, 95814 | |
| San Francisco Gen Hosp / UCSF AIDS Program | |
| San Francisco, California, United States, 94110 | |
| Tower ID Med Associates | |
| Los Angeles, California, United States, 90048 | |
| Kaiser Permanente / Infectious Disease | |
| Los Angeles, California, United States, 90027 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| HIV Clinical Research | |
| Fort Lauderdale, Florida, United States, 33316 | |
| United States, Georgia | |
| Ponce de Leon Ctr | |
| Atlanta, Georgia, United States, 30308 | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Rush Presbyterian St Lukes Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| United States, Maryland | |
| Natl Naval Med Ctr / Special Immunology Clinic | |
| Bethesda, Maryland, United States, 20889 | |
| United States, Massachusetts | |
| Boston Med Ctr / Clinical Research Office | |
| Boston, Massachusetts, United States, 02118 | |
| Brigham and Women's Hosp | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Univ Health Ctr 7D | |
| Detroit, Michigan, United States, 48201 | |
| United States, Missouri | |
| Kansas City Free Health Clinic | |
| Kansas City, Missouri, United States, 64111 | |
| United States, New Jersey | |
| Education & Research Building | |
| Camden, New Jersey, United States, 08103 | |
| Garden State Infectious Diseases / E I P Kennedy Health Sys | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New York | |
| Anderson Clinical Research | |
| New York, New York, United States, 10016 | |
| Albany Med College / Div of HIV Medicine | |
| Albany, New York, United States, 12208 | |
| CRIA | |
| New York, New York, United States, 10001 | |
| SUNY / Health Science Ctr at Brooklyn | |
| Brooklyn, New York, United States, 11203 | |
| New York Hosp of Queens / AIDS Ctr | |
| Flushing, New York, United States, 11355 | |
| St Vincents Hosp and Med Ctr / Div of HIV Med | |
| New York, New York, United States, 10011 | |
| United States, Ohio | |
| Akron City Hospital | |
| Akron, Ohio, United States, 44304 | |
| United States, Pennsylvania | |
| Anderson Clinical Research | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Thomas Jefferson Univ | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Texas | |
| Houston Clinical Research Network / Southhampton Med Group | |
| Houston, Texas, United States, 77098 | |
| United States, Utah | |
| Univ of Utah School Of Medicine / Div of Infec Disease | |
| Salt Lake City, Utah, United States, 84132 | |
More Information
| Study ID Numbers: | 246P, MK-0639 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002406 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Dose-Response Relationship, Drug HIV Protease Inhibitors |
Indinavir RNA, Viral Reverse Transcriptase Inhibitors |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Indinavir Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections HIV Protease Inhibitors |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |
