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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: | NCT00001075 |
To determine whether administration of a highly active antiretroviral treatment regimen consisting of ritonavir (ABT-538), zidovudine (AZT), and lamivudine (3TC) is associated with the restoration of delayed type hypersensitivity and lymphocyte proliferative responses in patients with moderately advanced HIV-1 infection. To better characterize in these patients the phenotype of the expanded lymphocyte subpopulations, as well as the genotype, phenotype, and cellular origin of viruses that persist after initiation of therapy, and the genotype and phenotype of drug-resistant isolates that emerge during therapy.
Although plasma viral load drops dramatically after initiation of powerful antiretrovirals, it does not drop to zero. It appears that a new steady state is reached, suggesting that a reservoir may exist of virus-producing cells, possibly cells of monocyte/macrophage lineage, that continue to produce a low level of virus despite antiretroviral treatment.
Condition | Intervention |
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HIV Infections |
Drug: Ritonavir Drug: Lamivudine Drug: Zidovudine |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Pilot Study to Evaluate the Immunologic Consequences of a Highly Active Antiretroviral Therapy Regimen (HAART) Consisting of Ritonavir (ABT-538), Zidovudine (AZT), and Lamivudine (3TC) in Moderately Advanced HIV-1 Disease |
Estimated Enrollment: | 55 |
Although plasma viral load drops dramatically after initiation of powerful antiretrovirals, it does not drop to zero. It appears that a new steady state is reached, suggesting that a reservoir may exist of virus-producing cells, possibly cells of monocyte/macrophage lineage, that continue to produce a low level of virus despite antiretroviral treatment.
Patients undergo 5 weeks of antiretroviral washout before initiating therapy with ritonavir alone for 9 days, followed by combination therapy with ritonavir, zidovudine, and lamivudine from day 10 through week 48. [AS PER AMENDMENT 1/31/97: The availability of the current, open-label study treatment has been extended to allow patients who have completed 48 weeks of therapy to continue protocol therapy until the last enrolled patient completes 48 weeks of study treatment.]
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
Prior Medication:
Required:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
[AS PER AMENDMENT 8/27/96: Immunization must be avoided during the antiretroviral washout period.]
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
[AS PER AMENDMENT 8/27/96: Immunization must be avoided prior to the antiretroviral washout period.]
Active substance abuse.
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
Rush Presbyterian - Saint Luke's Med Ctr | |
Chicago, Illinois, United States, 60612 | |
United States, Ohio | |
Case Western Reserve Univ | |
Cleveland, Ohio, United States, 44106 |
Study Chair: | Lederman M | |
Study Chair: | Kessler H |
Study ID Numbers: | ACTG 315 |
Study First Received: | November 2, 1999 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00001075 |
Health Authority: | United States: Federal Government |
Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents |
Zidovudine HIV Protease Inhibitors Ritonavir Lamivudine |
Virus Diseases Sexually Transmitted Diseases, Viral Ritonavir HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Lamivudine Zidovudine AIDS-Related Complex 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 Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |