Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals
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Purpose
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 | Intervention |
|---|---|
|
HIV Infections |
Biological: Influenza Virus Vaccine Biological: Pneumococcal Vaccine, Polyvalent (23-valent) Drug: Lamivudine |
| Study Type: | Interventional |
| Study Design: | 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 |
| Enrollment: | 0 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.]
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001080 History of Changes |
| Other Study ID Numbers: | ACTG 340, 11311 |
| Study First Received: | November 2, 1999 |
| Last Updated: | May 1, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
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 |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Lamivudine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on June 17, 2013