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AIDS Clinical Trials Unit

Investigators
Lertora, Juan
Institutions
Tulane University
Start date
1996
End date
2002
Objective

This proposal is to establish an ACTU with a main unit based at Tulane University Medical Center and a subunit at Louisiana state University Medical Center, both in New Orleans, with the following goals:

  1. To recruit 80 or more new patients per year into ACTG sponsored Phase I, II, III protocols for the treatment of HIV infection, opportunistic infections, and neurologic complications of AIDS.
  2. To use GCRC for Phase I and II clinical trials and pathogenesis-related exploratory trials of new treatments for HIV.
  3. To establish support laboratories to perform protocol mandated studies in virology, pharmacology, and immunology.
  4. To systematically address women's health-related issues.
  5. To recruit an ethnically diverse population of patients, representative of the regional population, in order to give minority populations and women access to ACTG clinical trials.
  6. To address the subjects of compliance and patient retention, including outreach programs.
  7. To work with the local CAB to include local patients and their advocates in the implementation of the ACTU research agenda.
More information

Scientifically the following areas will be emphasized:

  1. Phase I pharmacokinetic, drug interactions, and toxicity studies, and pilot studies of HIV pathogenesis;
  2. Correlations of plasma and intracellular drug levels with changes in viral load;
  3. Pathogenesis of HIV and HTLV-I/II co-infection;
  4. Therapy of HIV-induced thrombocytopenia;
  5. HIV neuropathy;
  6. Immune resistance of HIV;
  7. Mechanisms and prevention of HIV-induced apoptosis;
  8. Therapy of opportunistic diseases (mainly microporidiosis and mycobacterial infections);
  9. Pathogenesis and therapy of cervical dysplasia in HIV infected women.
Funding Source
Nat'l. Inst. of Allergy and Infectious Diseases
Project number
3U01AI038844-04S1
Categories
Sanitation and Quality Standards
Natural Toxins
Viruses and Prions
Bacterial Pathogens