Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Influenza Virus Vaccine (Biological); Pneumococcal Vaccine, Polyvalent (23-valent) (Biological); Lamivudine (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Kuritzkes D, Study Chair
Richman D, Study Chair
Havlir D, Study Chair
Summary
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).
Clinical Details
Official title: Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals
Study design: Treatment, Parallel Assignment
Detailed 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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.]
Locations and Contacts
Univ of California / San Diego Treatment Ctr, San Diego, California 921036325, United States
Univ of Colorado Health Sciences Ctr, Denver, Colorado 80262, United States
Additional Information
Click here for more information about Lamivudine
Last updated: June 23, 2005
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