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Clinical Trials You May Wish to Enroll In

From San Francisco General Hospital

February 1998

In the last issue of AIDS Care we offered our readers some helpful guidelines for deciding whether or not to participate in one or more of the scores of clinical trials that are currently enrolling people with HIV. That article -- entitled "Should You Participate in Clinical Trials?" -- listed both the pros and the cons of participation in these trials. It provided readers with a short glossary of terms used in clinical trials, and it concluded with a list of questions that prospective participants should ask -- and expect to have answered -- before enrolling in any clinical trial.

We encouraged prospective participants to discuss their options with their regular healthcare providers, with the organizers of the trial or trials, and with fellow patients -- especially those who have experience participating in such trials. For people who are not doing well on the currently available treatments, clinical trials are a way of gaining access to new drugs that may prove more effective. Clinical trials are also a way for individuals with little or no health insurance to obtain treatments they might not otherwise be able to afford, and these trials generally provide all participants with extra medical care at no cost.

This pull out and save section lists a number of large-scale national clinical trials that are currently enrolling HIV-infected individuals. The table indicates the drugs being tested, the criteria for enrollment (clinical status, CD4 count, viral load, previous drug experience), and the duration of the studies. Decisions about participation should be made in consultation with your regular care providers. For further information about these and other trials, call 1-800-TRIALS-A.

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Adult Trials
Trial Study Drugs Status CD4/RNA Placebo? Duration Special
FDA 228B AZT, 3TC, delavirdine 1,2,3 200-500/NS Yes 2 years No prior ddC, d4T, 3TC, or ddI
FDA 232D adefovir, indinavir, AZT, 3TC 1,3 >100/>5000 No 48 wks No prior PI or adefovir
FDA 232E adefovir, nelfinavir, saquinavir SGC 1,3 >100/>5000 No 48 wks No prior PI or adefovir
FDA 238D abacavir, 3TC, AZT 1,2,3 >100/NS No 48 wks No prior antiretroviral therapy
FDA 246G indinavir, AZT, 3TC 1 >500/>1000 No 4 years No prior antiretroviral therapy
FDA 260A indinavir, 3TC, d4T, AZT 1 200-700/>10,000 No 48 wks No prior antiretroviral therapy
FDA 244C nelfinavir, d4T, ddI, hydroxyurea 1 >500/NS No 96 wks No prior antiretroviral therapy
FDA 264E abacavir, indinavir, all nucleosides 1,2 NS/>400 No 48 wks No prior PI treatment
ACTG 325 Interleukin-II 1,2,3 <50 and 300-500/NS Yes 4 wks Stable on at least 2 drugs
ACTG 359 saquinavir SGC, ritonavir, nelfinavir, delavirdine, adefovir 1,2,3 NS/2000-20,000 Yes 24-48 wks At least 6 months prior indinavir
*Notes: The studies employ several arms, multiple combinations of the drugs listed, and sometimes different doses. All study participants may not get each drug listed. "Placebo" means that placebo is a possibility, not a certainty. Many other inclusion/exclusion criteria apply, but we have tried to mention the most significant ones. These studies are in a variety of cities in the United States; to find out if a particular trial is available in your city, call 1-800-TRIALS-A. For any other information about these or other trials, call 1-800-TRIALS-A. A listing here does not constitute a specific endorsement by the editors of AIDS Care.
**Key/Abbreviations: Clinical status 1=asymptomatic, 2=symptomatic, 3=diagnosis of AIDS; NS: not specified; SGC: soft-gel capsule; PI: protease inhibitor.


Pediatric Trials
Trial Study Drugs Status CD4/RNA Placebo? Duration Special
FDA 238E abacavir 1,3 <15%/>100,000 No NS High risk for progression
Ages 6 mo-13 yrs
FDA 238L abacavir, AZT, 3TC 1,2,3 >15%/NS No 48 wks >12 wks prior antiretroviral therapy
Ages 3 mo-12 yrs
FDA 264C 141W94, all nucleosides 1,2,3 NS/>10,000 Yes 48 wks No prior PI
Ages 6 mo-18 yrs
*Notes: The studies employ several arms, multiple combinations of the drugs listed, and sometimes different doses. All study participants may not get each drug listed. "Placebo" means that placebo is a possibility, not a certainty. Many other inclusion/exclusion criteria apply, but we have tried to mention the most significant ones. These studies are in a variety of cities in the United States; to find out if a particular trial is available in your city, call 1-800-TRIALS-A. For any other information about these or other trials, call 1-800-TRIALS-A. A listing here does not constitute a specific endorsement by the editors of AIDS Care.
**Key/Abbreviations: Clinical status 1=asymptomatic, 2=symptomatic, 3=diagnosis of AIDS; NS: not specified; SGC: soft-gel capsule; PI: protease inhibitor.





  
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This article was provided by San Francisco General Hospital. It is a part of the publication AIDS Care.
 
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