NCT00001080

Brief 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).

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

Lymphocyte TransformationHIV-1Drug Resistance, MicrobialCD4-Positive T-LymphocytesLamivudineInfluenza VaccineRNA, ViralBacterial VaccinesAnti-HIV AgentsPneumonia, PneumococcalViral Load

Interventions

Influenza Virus VaccineBIOLOGICAL
Pneumococcal Vaccine, Polyvalent (23-valent)BIOLOGICAL
LamivudineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV InfectionsInfluenza, HumanPneumonia, Pneumococcal

Interventions

Influenza VaccinesPneumococcal VaccinesLamivudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesRespiratory Tract InfectionsOrthomyxoviridae InfectionsRespiratory Tract DiseasesPneumococcal InfectionsStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesPneumonia, BacterialPneumoniaLung Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex MixturesStreptococcal VaccinesBacterial VaccinesZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Study Officials

  • Kuritzkes D

    STUDY CHAIR

  • Richman D

    STUDY CHAIR

  • Havlir D

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

November 1, 2021

Record last verified: 2021-10