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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: | NCT00001080 |
To ascertain whether the origin of plasma HIV-1-RNA following T cell activation represents the activation of latently infected cells or an increase in cells permissive for replacing viral mutants.
The mechanism by which immune stimulation increases circulating levels of HIV-1 is not known. In particular, it is uncertain whether the transient increase in plasma HIV-1 RNA is due to enhanced replication of an actively replicating pool of HIV-1, or is due instead to activation of proviral sequences in previously resting CD4+ cells. One approach to discriminate these alternatives is a "molecular pulse-chase" experiment. In this approach, drug resistant mutants would be selected by administration of Lamivudine (3TC).
Condition | Intervention |
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HIV Infections |
Biological: Influenza Virus Vaccine Biological: Pneumococcal Vaccine, Polyvalent (23-valent) Drug: Lamivudine |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment |
Official Title: | Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals |
Estimated Enrollment: | 20 |
The mechanism by which immune stimulation increases circulating levels of HIV-1 is not known. In particular, it is uncertain whether the transient increase in plasma HIV-1 RNA is due to enhanced replication of an actively replicating pool of HIV-1, or is due instead to activation of proviral sequences in previously resting CD4+ cells. One approach to discriminate these alternatives is a "molecular pulse-chase" experiment. In this approach, drug resistant mutants would be selected by administration of Lamivudine (3TC).
Twenty subjects without prior 3TC experience will be treated with 3TC for 2 weeks. On day 14, half of the subjects will receive immunization with both the influenza and pneumococcal vaccine. 3TC will be discontinued at this time. Patients will be followed for 4 weeks after the immunization.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with any of the following prior conditions are excluded:
Prior Medication:
Excluded:
Excluded within 30 days of study entry:
Excluded within 1 year of study entry:
Treatment with an influenza and/or pneumonia vaccine
[AS PER AMENDMENT 1/23/97:
[AS PER AMENDMENT 1/23/97:
United States, California | |
Univ of California / San Diego Treatment Ctr | |
San Diego, California, United States, 921036325 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 |
Study Chair: | Kuritzkes D | |
Study Chair: | Richman D | |
Study Chair: | Havlir D |
Study ID Numbers: | ACTG 340 |
Study First Received: | November 2, 1999 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00001080 |
Health Authority: | United States: Federal Government |
Lymphocyte Transformation HIV-1 Drug Resistance, Microbial CD4-Positive T-Lymphocytes Lamivudine Influenza Vaccine |
RNA, Viral Bacterial Vaccines Anti-HIV Agents Pneumonia, Pneumococcal Viral Load |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Influenza, Human |
Pneumonia, Pneumococcal Lamivudine Retroviridae Infections Immunologic Deficiency Syndromes Pneumonia |
Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |