Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations i… (NCT00001080) | Clinical Trial Compass
WithdrawnNot Applicable
Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals
Stopped: as of 4/23/97
0
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 acut…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00001080
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)