San Francisco General Hospital • Pull Out and Save

Selected Clinical Trials Open to Patients with HIV Disease

An Abbreviated List of Open Clinical Trials Involving Various Combinations of Antiretroviral Agents, Some Approved and Some Experimental

February 1998

This article is part of TheBody.com's archive. Because it contains information that may no longer be accurate, this article should only be considered a historical document.

In the last issue of AIDS Care we offered 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 (see "Should You Participate in Clinical Trials?" in the December 1997 issue). That article listed both the pros and the cons of participation in these trials, provided readers with a short glossary of terms used in clinical trials, and 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 trial organizers, and with fellow patients -- especially those who have experience participating in such trials. For patients 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 antiretroviral agents being tested, inclusion/exclusion criteria (clinical status, CD4 count, viral load, previous drug experience), and the duration of the studies. The editors of HIV Newsline will update this list at appropriate intervals. For further information about these and other trials, call 1-800-TRIALS-A.

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 anti- retroviral therapy
FDA 246G	indinavir, AZT, 3TC	1	>500/>1000	No	4 years	No prior anti- retroviral therapy
FDA 260A	indinavir, 3TC, d4T, AZT	1	200-700/ >10,000	No	48 wks	No prior anti- retroviral therapy
FDA 244C	nelfinavir, d4T, ddI, hydroxyurea	1	>500/NS	No	96 wks	No prior anti- retroviral 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
PEDIATRIC TRIALS
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 anti- retroviral 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

Back to the February 1998 HIV Newsline contents page.

This article is part of TheBody.com's archive. Because it contains information that may no longer be accurate, this article should only be considered a historical document.

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

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