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Active Clinical Trials

The following clinical trials (drug studies) are currently active at Davies Medical Center. If you would like more information about any of these trials, or would like to be considered as a participant, please contact the Institute for HIV Research & Treatment at (415) 565-6660.

Title: A Randomized, Open-Label Trial of High Dose Atovaquone versus Low Dose Atovaquone versus Aerosolized Pentamidine for Prophylaxis of Pneumocystis carinii Pneumonia in Patients with HIV Infection Who are intolerant of TMP/SMX

Ref: 213
Drugs: Atovaquone, an antibacterial. Pentamadine, aerosolized: antiparasitic
Purpose: To find out if high dose atovaquone in liquid form is effective in preventing AIDS pneumonia (Pneumocystis carinii Pneumonia, or PCP) in patients who cannot take Septra or Bactrim (TMP/SMX) and who have had one or more episodes of PCP. To learn about the safety of liquid high dose atovaquone.
Requirements:
  • T-cell count below 200 or have had PCP before
  • Cannot take Septra or Bactrim because of side effects
  • At least 13 years old
  • Not Allowed:
  • Taking any other drugs which act against PCP
  • Active PCP. If patient has active PCP, it must be treated before starting the study.
  • Title: A Multicenter, Randomized, Open-Label Phase I/II pilot Study of an Investigational New Drug (IND) and Oral Ganciclovir in Combination and Alone in HIV-Infected Persons with CD4 Cell Counts < 100 cells/mm3 and CMV Viruria

    Ref: 22-95-503
    Drugs: Oral Ganciclovir, antiviral.
    Reimbursement: $450 for completed participation in study.
    Purpose: The purpose of this study is to determine the safety and anti-cytomegalovirus (CMV) activity of this IND alone, oral ganciclovir alone and this IND in combination with oral ganciclovir in HIV-infected individuals with CD4 counts less than 100 cells/mm3 and a positive CMV urine culture.
    Requirements:
  • T-cells less than 100
  • Not Allowed:
  • Previous treatment for CMV infection
  • Use of protease inhibitors during study
  • History of heart disease.
  • Title: A Double-Blind, Randomized, Combination Therapy Trial of Delavirdine (DLV) and Zidovudine (ZDV) and Lamivudine (3TC) versus DLV and ZDV versus ZDV and 3TC as Initial Therapy or Following Part I Therapy in HIV-1 Infected Individuals with CD4 Counts of 200-500/mm3 (Part II)

    Ref: M/3331/0021
    Drugs: Delavirdine, AZT, 3TC
    Purpose: To find out if the drug delavirdine mesylate (DLV) combined with AZT and 3TC is better than AZT plus 3TC or AZT plus DLV in treating people with HIV. Delavirdine works different than AZT or drugs like it, it is called a non-nucleoside reverse transcriptase inhibitor.
    Requirements:
  • CD4 cell (T-cell) range: 200-500
  • At least 14 years old
  • Not Allowed:
  • AZT prior use of more than 6 months
  • Prior use of ddI, ddC, d4T, 3TC, L-drugs, TIBO, HEPT, atevirdine
  • Active opportunistic infection, nervous system disorder or muscle disease
  • Women who are pregnant or breast-feeding
  • Title: An Open-Label, Multiple-Dose, Multicenter Study of the Safety and Efficacy of Ritonavir in Combination with Saquinavir in HIV-Infected Patients

    Ref: M96-462
    Drugs: Ritonavir and Saquinavir, both are protease inhibitors.
    Purpose: To test the safety and effectiveness of ritonavir and saquinavir taken together in various doses for 48 weeks. These doses have been selected based on the results from other studies.
    Requirements:
  • At least 12 years old
  • T-cell count between 100 - 500
  • Not Allowed:
  • Prior use of any Protease Inhibitors
  • Active opportunistic infections or inflammation of the pancreas
  • Taking any medications contra-indicated for use with Ritonavir
  • If you are taking any antiretrovirals (AZT, ddC, ddI, 3TC, D4T), you will be asked to stop taking them two weeks prior to starting therapy.
  • Title: A Multicenter, Open-Label Study of the Safety and Activity of Saquinavir Soft Gelatin Capsule Formulation (Saquinavir-SGC) in combination with Other Antiretroviral Drugs.

    Ref: NV 15182B
    Drugs: Saquinavir Soft Gelatin Capsule, a protease inhibitor. Antiretrovirals may be used in combination but are not supplied by the sponsor.
    Purpose: The purpose of this study is to find out if adding saquinavir-SGC to other approved HIV therapies is safe and if this combination improves the ability of these drugs to slow down the growth of HIV. Approximately 60 healthy, non-HIV infected persons and 88 HIV infected persons have received saquinavir-SGC for as long as 6 months, in different studies, and saquinavir-SGC has been generally well tolerated.
    Requirements:
  • Study ongoing but closed to enrollment.
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