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

Keywords

ClinConnect Summary

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
• \[AS PER AMENDMENT 1/23/97:
• • influenza vaccine only\].
• \[AS PER AMENDMENT 1/23/97:
• * Excluded within 3 years of study entry:
• • Pneumonia vaccine.\]

Trial Officials