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.
| 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. | ||||||
| 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. | ||||||