HIV InfectionsNCT00001080
Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals
A study testing Influenza Virus Vaccine, Pneumococcal Vaccine, Polyvalent (23-valent) and Lamivudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Influenza Virus Vaccine, Pneumococcal Vaccine, Polyvalent (23-valent) and Lamivudine
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- One plasma HIV-1 RNA level between >= 20,000 and < 120,000 copies/ml.
- Prior Medication:
- Allowed:
- Stable antiretroviral therapy.
Who cannot join
- 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.
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- 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.]
About this study
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).
Read the detailed 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.
- Conditions
- HIV Infections
- Being tested
- Influenza Virus Vaccine, Pneumococcal Vaccine, Polyvalent (23-valent), Lamivudine
- Keywords
- Lymphocyte Transformation, HIV-1, Drug Resistance, Microbial, CD4-Positive T-Lymphocytes, Lamivudine, Influenza Vaccine, RNA, Viral, Bacterial Vaccines, Anti-HIV Agents, Pneumonia, Pneumococcal, Viral Load
- Medical subject headings
- HIV Infections, Influenza, Human, Pneumonia, Pneumococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza Virus VaccineBiological
Pneumococcal Vaccine, Polyvalent (23-valent)Biological
LamivudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Why it stopped: as of 4/23/97
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kuritzkes D, Study chairRichman D, Study chairHavlir D, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001080
- Sponsor's protocol ID
- ACTG 340
- Other IDs
- 11311
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 1 Nov 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals
- ClinicalTrials.gov ID
- NCT00001080
- Acronym / sponsor ID
- ACTG 340
- Conditions
- HIV Infections
- Keywords
- Lymphocyte Transformation, HIV-1, Drug Resistance, Microbial, CD4-Positive T-Lymphocytes, Lamivudine, Influenza Vaccine, RNA, Viral, Bacterial Vaccines
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: as of 4/23/97
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Antiretroviral therapy, provided the patient has been on the same dose and drugs for 60 days prior to study entry.
- Documented HIV infection.
- CD4 lymphocyte count of > 300 cells/mm3.
- One plasma HIV-1 RNA level between >= 20,000 and < 120,000 copies/ml.
- Stable antiretroviral therapy.
Key exclusion criteria (35 listed)
- 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.
- Systemic chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza Virus Vaccine | Biological | – |
| Pneumococcal Vaccine, Polyvalent (23-valent) | Biological | – |
| Lamivudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuritzkes D study chair
Richman D study chair
Havlir D study chair
Questions about this trial
What is this clinical trial studying?
A study testing Influenza Virus Vaccine, Pneumococcal Vaccine, Polyvalent (23-valent) and Lamivudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.