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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

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

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
TrialStudy DrugsStatusCD4/RNAPlacebo?DurationSpecial
FDA
228B
AZT, 3TC,
delavirdine
1,2,3200-500/NSYes2 yearsNo prior ddC, d4T,
3TC, or ddI
FDA
232D
adefovir, indinavir,
AZT, 3TC
1,3>100/>5000No48 wksNo prior PI or
adefovir
FDA
232E
adefovir, nelfinavir,
saquinavir SGC
1,3>100/>5000No48 wksNo prior PI or
adefovir
FDA
238D
abacavir, 3TC,
AZT
1,2,3>100/NSNo48 wksNo prior anti-
retroviral therapy
FDA
246G
indinavir, AZT,
3TC
1>500/>1000No4 yearsNo prior anti-
retroviral therapy
FDA
260A
indinavir, 3TC,
d4T, AZT
1200-700/
>10,000
No48 wksNo prior anti-
retroviral therapy
FDA
244C
nelfinavir, d4T, ddI,
hydroxyurea
1>500/NSNo96 wksNo prior anti-
retroviral therapy
FDA
264E
abacavir, indinavir,
all nucleosides
1,2NS/>400No48 wksNo prior PI
treatment
ACTG
325
Interleukin-II1,2,3<50 and
300-500/NS
Yes4 wksStable on at
least 2 drugs
ACTG
359
saquinavir SGC,
ritonavir, nelfinavir,
delavirdine, adefovir
1,2,3NS/2000-
20,000
Yes24-48 wksAt least 6 months
prior indinavir
PEDIATRIC TRIALS
FDA
238E
abacavir1,3<15%/
>100,000
NoNSHigh risk for
progression
Ages 6 mo-13 yrs
FDA
238L
abacavir, AZT,
3TC
1,2,3>15%/NSNo48 wks>12 wks prior anti-
retroviral therapy
Ages 3 mo-12 yrs
FDA
264C
141W94, all
nucleosides
1,2,3NS/>10,000Yes48 wksNo prior PI
Ages 6 mo-18 yrs

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A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!



  
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This article was provided by San Francisco General Hospital. It is a part of the publication HIV Newsline.
 
See Also
Clinical Trials: Archive 1997 - 2000

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