Current ACTU Trials

AIDS Clinical Trials Unit (ACTU) -
ACTG (AIDS Clinical Trials Group) & Drug Company Studies

The University of Texas Medical Branch
Galveston, Texas

March 2007

HIV research volunteers make a difference! Clinical trials have helped to make it possible for people with HIV/AIDS to live longer, healthier lives. The AIDS Clinical Trials Unit (ACTU) at UTMB Galveston has been conducting clinical trials for the treatment of HIV/AIDS, opportunistic infections and associated conditions since 1992. These trials or studies are sponsored by the adult AIDS Clinical Trials Group (ACTG), National Institutes of Health, and by private pharmaceutical companies.

HIV-infected men and women, ages 18 and over, of all ethnicities and cultures are needed to take part in clinical trials. Study drug(s) and study-related clinic visits, exams and labs are provided at no cost to study participants. Assistance with travel and/or childcare expenses may be available. Exam and lab results can be shared with the participant’s primary care provider if desired.

To find out more, please call the ACTU at (409) 747-0214 or toll free 877-324-ACTU (2288).

Naïve or New to HIV Treatment

- Glaxo EPZ108859: Safety and Efficacy of an Initial Regimen of Atazanavir + Ritonavir + the
    Abacavir/Lamivudine Fixed Dose Combination Tablet (ABC/3TC FDC) for 36 weeks Followed by
    Simplification to Atazanavir with ABC/3TC FDC or Maintenance of the Initial Regimen for
    Additional 48 Weeks in Antiretroviral Therapy Naïve HIV-1 Infected HLA-B*5701 Negative
    Subjects

    Naïve 96 week trial with Atazanavir/Ritonavir & Epzicom. Responding patients are randomized at week 36 to
    either continuing or discontinuing Ritonavir for another 48 weeks. HIV RNA >1000, no hepatitis B, screening
    genotyping results must reveal that therapy is appropriate. No serious cardiac problems or conduction
    abnormalities. Contact Cheryl.

On HIV Treatment – Treatment Failure or Intolerance

- BMS AI424128 (BMS 128): A Phase IV, Multi-Center, Cross-sectional study to evaluate the 150L substitution among subjects experiencing virologic failure on a HAART regimen containing atazanavir (ATV)

Single visit study for patients experiencing virologic failure on HAART regimen containing Atazanavir. Checking the prevalence of 150L substitution. Will remain “on study” until results are available. May be asked to have 2^nd blood draw. Travel reimbursement provided. Contact Gerianne

- Abbott M06-802: A Phase 3, Randomized, Open-label Study of Lopinavir/ritonavir Tablets 800/200 mg Once-daily Versus 400/100 mg Twice-daily when Coadministered with Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-experienced, HIV-1 Infected Subjects

Open label 48 week study of Kaletra 800/200 mg once daily versus Kaletra 400/100 mg twice daily co-administered with NRTI's. Eligibility: Failing HAART regimen; two consecutive HIV-RNA > 400, with last HIV RNA > 1,000; use of Kaletra deemed appropriate by investigator based on resistance testing at screening. No prior Kaletra. Contact: Cheryl

Hepatitis Co-Infection

No immune restoration studies enrolling at present time

Immune Restoration

No immune restoration studies enrolling at present time

HIV Complications or Conditions

No HIV Complication or Condition studies enrolling at present time

Gender Specific Studies: Women

No women-specific studies enrolling at present time.

Other

No other HIV/AIDS related studies enrolling at present time.

Pending Studies

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