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Clinical Trials You May Wish to Enroll In

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.


Adult Trials
TrialStudy DrugsStatusCD4/RNAPlacebo?DurationSpecial
FDA 228BAZT, 3TC, delavirdine1,2,3200-500/NS Yes 2 years No prior ddC, d4T, 3TC, or ddI
FDA 232Dadefovir, indinavir, AZT, 3TC1,3>100/>5000No48 wksNo prior PI or adefovir
FDA 232Eadefovir, nelfinavir, saquinavir SGC1,3>100/>5000No48 wksNo prior PI or adefovir
FDA 238Dabacavir, 3TC, AZT1,2,3>100/NSNo48 wks No prior antiretroviral therapy
FDA 246Gindinavir, AZT, 3TC 1 >500/>1000 No 4 yearsNo prior antiretroviral therapy
FDA 260Aindinavir, 3TC, d4T, AZT1200-700/>10,000 No48 wksNo prior antiretroviral therapy
FDA 244Cnelfinavir, d4T, ddI, hydroxyurea1 >500/NSNo96 wksNo prior antiretroviral therapy
FDA 264Eabacavir, indinavir, all nucleosides1,2NS/>400No48 wksNo prior PI treatment
ACTG 325Interleukin-II1,2,3<50 and 300-500/NS Yes4 wksStable on at least 2 drugs
ACTG 359saquinavir SGC, ritonavir, nelfinavir, delavirdine, adefovir1,2,3NS/2000-20,000Yes24-48 wksAt 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
TrialStudy DrugsStatusCD4/RNAPlacebo?DurationSpecial
FDA 238Eabacavir1,3<15%/>100,000NoNSHigh risk for progression
Ages 6 mo-13 yrs
FDA 238Labacavir, AZT, 3TC1,2,3>15%/NSNo48 wks >12 wks prior antiretroviral therapy
Ages 3 mo-12 yrs
FDA 264C141W94, all nucleosides1,2,3NS/>10,000Yes48 wksNo 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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