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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00001080
Other study ID # ACTG 340
Secondary ID 11311
Status Withdrawn
Phase N/A
First received
Last updated

Study information

Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.]

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Influenza Virus Vaccine

Pneumococcal Vaccine, Polyvalent (23-valent)

Drug:
Lamivudine


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
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