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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001085 |
To determine the proportion of patients whose plasma HIV-1 RNA level remains below a detectable level (less than 500/ml) after 24 weeks of study therapy with either 141W94 monotherapy or 141W94 plus zidovudine (ZDV) and lamivudine (3TC). To determine the safety and tolerability of 141W94 monotherapy and the combination of 141W94 plus 3TC in patients with HIV infection.
Although dramatic inhibition of HIV-1 replication is achieved with ritonavir or indinavir monotherapy, in both cases maximum suppression required combination treatment together with nucleoside analog RT inhibitors. This study tests the hypothesis that monotherapy with 141W94 doses that result in Cmin levels far in excess of the IC90 corrected for plasma protein binding for HIV-1 can achieve the same virologic and immunologic effects in terms of magnitude and durability, as has been observed with combinations of other protease inhibitors plus nucleoside analogs.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Amprenavir Drug: Lamivudine Drug: Zidovudine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Randomized, Double-Blind, Phase II Study of 141W94 (VX-478) Monotherapy vs. 141W94 (VX-478) Plus ZDV Plus 3TC in HIV Infected Individuals |
Estimated Enrollment: | 94 |
Although dramatic inhibition of HIV-1 replication is achieved with ritonavir or indinavir monotherapy, in both cases maximum suppression required combination treatment together with nucleoside analog RT inhibitors. This study tests the hypothesis that monotherapy with 141W94 doses that result in Cmin levels far in excess of the IC90 corrected for plasma protein binding for HIV-1 can achieve the same virologic and immunologic effects in terms of magnitude and durability, as has been observed with combinations of other protease inhibitors plus nucleoside analogs.
In this randomized, double-blind study, patients' HIV RNA is screened 30 days prior to entry. Patients satisfying enrollment criteria must have been on a stable antiretroviral regimen for 30 days prior to study screening and remain on the same regimen until entry. Patients are stratified based on the screening HIV-1 RNA copy number obtained within 30 days of entry: 5,000 - 50,000 copies/ml versus greater than 50,000 copies/ml. In addition, patients are stratified based on previous antiretroviral use: naive versus experienced. Patients are randomized to one of 2 treatment arms: Arm A - 141W94, plus Zidovudine (ZDV) and Lamivudine (3TC) or Arm B - 141W94, plus ZDV placebo and 3TC placebo.
[AS PER AMENDMENT 8/25/97: Patients assigned to the monotherapy arm are advised to discontinue their study medication immediately and initiate antiretroviral therapy with indinavir, nevirapine, stavudine and 3TC, as outlined in ACTG 347 roll-over protocol, ACTG 373. Patients in the three-drug arm continue on study therapy.] [AS PER AMENDMENT 12/19/97: Patients receive study treatment for 56 weeks and are followed through week 68.]
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Regularly prescribed medications such as:
NOTE:
Patients must have:
Prior Medication: Required:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
NOTE:
Patients with the following prior symptoms and conditions are excluded:
Prior Medication:
Excluded:
Any antiretroviral therapy change within 30 days prior to study screening.
1. Concurrent use of non-protocol specified antiretroviral agents; either investigational or licensed.
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Univ of Southern California / LA County USC Med Ctr | |
Los Angeles, California, United States, 900331079 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Florida | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 331361013 | |
United States, Georgia | |
Emory Univ | |
Atlanta, Georgia, United States, 30308 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
Rush Presbyterian - Saint Luke's Med Ctr | |
Chicago, Illinois, United States, 60612 | |
Cook County Hosp | |
Chicago, Illinois, United States, 60612 | |
United States, Massachusetts | |
Beth Israel Deaconess - West Campus | |
Boston, Massachusetts, United States, 02215 | |
Boston Med Ctr | |
Boston, Massachusetts, United States, 02118 | |
United States, Missouri | |
St Louis Regional Hosp / St Louis Regional Med Ctr | |
St Louis, Missouri, United States, 63112 | |
United States, New York | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
United States, North Carolina | |
Univ of North Carolina | |
Chapel Hill, North Carolina, United States, 275997215 | |
United States, Pennsylvania | |
Univ of Pennsylvania at Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, South Carolina | |
Julio Arroyo | |
West Columbia, South Carolina, United States, 29169 |
Study Chair: | Murphy R | |
Study Chair: | Gulick R |
Study ID Numbers: | ACTG 347 |
Study First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00001085 |
Health Authority: | United States: Federal Government |
HIV-1 Drug Therapy, Combination Acquired Immunodeficiency Syndrome Zidovudine HIV Protease Inhibitors Lamivudine |
RNA, Viral VX 478 Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
Virus Diseases Amprenavir Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Lamivudine Zidovudine Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection Antiviral Agents |
Pharmacologic Actions Protease Inhibitors Antibiotics, Antitubercular Reverse Transcriptase Inhibitors Anti-Bacterial Agents Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Antitubercular Agents Nucleic Acid Synthesis Inhibitors |