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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Withdrawn

CT.gov ID

NCT00001080

Collaborator

(none)

Enrollment

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Biological: Influenza Virus Vaccine Biological: Pneumococcal Vaccine, Polyvalent (23-valent) Drug: Lamivudine	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.