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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001080 |
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 |
| MedlinePlus related topics: | AIDS Flu |
| Drug Information available for: | Lamivudine Influenza Vaccines Fluvirin Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment |
| Official Title: | Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals |
| Estimated Enrollment: | 20 |
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:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with any of the following prior conditions are excluded:
Prior Medication:
Excluded:
Excluded within 30 days of study entry:
Excluded within 1 year of study entry:
Treatment with an influenza and/or pneumonia vaccine
[AS PER AMENDMENT 1/23/97:
[AS PER AMENDMENT 1/23/97:
Contacts and Locations| United States, California | |||||
| Univ of California / San Diego Treatment Ctr | |||||
| San Diego, California, United States, 921036325 | |||||
| United States, Colorado | |||||
| Univ of Colorado Health Sciences Ctr | |||||
| Denver, Colorado, United States, 80262 | |||||
| Study Chair: | Kuritzkes D | |
| Study Chair: | Richman D | |
| Study Chair: | Havlir D |
More Information
Click here for more information about Lamivudine 
  |
| Study ID Numbers: | ACTG 340 |
| First Received: | November 2, 1999 |
| Last Updated: | August 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001080 |
| Health Authority: | United States: Federal Government |
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