Search / Trial NCT00001080

Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of December 09, 2023

Withdrawn

Keywords

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

Description

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 fo...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Antiretroviral therapy, provided the patient has been on the same dose and drugs for 60 days prior to study entry.
  • Patients must have:
  • Documented HIV infection.
  • CD4 lymphocyte count of > 300 cells/mm3.
  • One plasma HIV-1 RNA level between >= 20,000 and < 120,000 copies/ml.
  • Prior Medication:
  • Allowed:
  • Stable antiretroviral therapy.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Presence of an AIDS defining opportunistic infection, including Kaposi's sarcoma.
  • Allergy to influenza or pneumococcal vaccine or their components; to egg or egg products.
  • Unexplained temperature >= 38.5 degrees C for 7 consecutive days within the 30 days prior to study entry.
  • Concurrent participation in other experimental therapies.
  • Concurrent Medication:
  • Excluded:
  • Systemic chemotherapy.
  • Steroids.
  • Corticosteroids.
  • Vaccinations.
  • Any new antiretroviral agents that the patient was not taking at the time of study entry and not prescribed by the study.
  • Colony stimulating factors including G-CSF or rEPO.
  • Immune modulators/immune based therapies.
  • Concurrent Treatment:
  • Excluded:
  • Radiation therapy.
  • Transfusion dependent patients.
  • Patients with any of the following prior conditions are excluded:
  • History of an AIDS defining opportunistic infection, including Kaposi's sarcoma (except limited cutaneous diseases [< 5 lesions]).
  • History of acute or chronic pancreatitis.
  • Prior Medication:
  • Excluded:
  • Prior treatment with 3TC.
  • Excluded within 30 days of study entry:
  • Treatment with immune modulators.
  • Acute or chronic therapy for recognized infections (eg, influenza, HSV, VZV).
  • Excluded within 1 year of study entry:
  • Treatment with an influenza and/or pneumonia vaccine
  • [AS PER AMENDMENT 1/23/97:
  • influenza vaccine only].
  • [AS PER AMENDMENT 1/23/97:
  • Excluded within 3 years of study entry:
  • Pneumonia vaccine.]

Attachments

readout_NCT00001080_2023-12-09.pdf

4.5 MB

NCT00001080_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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