Suspended

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

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What is being tested

Influenza Virus Vaccine

+ Pneumococcal Vaccine, Polyvalent (23-valent)
+ Lamivudine
Biological
Drug
Who is being recruted

HIV Infections

Over 18 Years
How is the trial designed

Treatment Study

Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 1, 2021
Sourced from a government-validated database.Claim as a partner

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). 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.

Official TitleEffect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 1, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
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 \[AS PER AMENDMENT 1/23/97: * influenza vaccine only\]. \[AS PER AMENDMENT 1/23/97: * Excluded within 3 years of study entry: * Pneumonia vaccine.\]



Study Centers

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SuspendedNo study centers