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Clinical Trials for Individuals Failing Current Therapy

October 1999

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 As a result, parts of this article may be outdated.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!

A decade ago, there were only two therapeutic options for people who tested positive for the human immunodeficiency virus: You could take AZT . . . or you could elect not to take AZT. If you chose therapy, you got some benefit -- partial suppression of viral replication, and a modest rebound in your CD4 count -- and these benefits often lasted for several years before they began to wane. If you chose to eschew AZT monotherapy, you were spared the side effects of therapy . . . but you were denied its benefits.

Today, individuals who are beginning antiretroviral therapy have dozens of therapeutic options -- and they have virtual assurance that whatever regimen they choose will suppress viral replication to levels so low they cannot be measured by the most sensitive of the commercially available HIV RNA assays. Moreover, they now have the option of choosing their initial anti-HIV regimen with its successor in mind. Newly diagnosed patients can begin their treatment with a combination of three nucleoside analogs -- AZT, 3TC, and abacavir, for example. Or they can start therapy with two nucleosides and a non-nucleoside reverse-transcriptase inhibitor -- say, d4T, 3TC, and either nevirapine or efavirenz.

In most treatment-naïve individuals, any one of these combinations will suppress viral replication to undetectable levels for a period of time ranging from months to years. And all of these therapeutic choices defer the use of the most powerful class of antiretroviral agents, the protease inhibitors, until a later date -- thereby reserving these potent drugs for use down the road.

But what about the thousands of HIV-positive people who are veterans of two, three, or even four antiretroviral regimens? For these treatment-experienced individuals, who have, over the years, moved from two-nucleoside therapy to an NNRTI-containing regimen, and from there to the first of several multidrug therapies that contained at least one protease inhibitor, the therapeutic options are much more limited. Some of these treatment veterans have developed high-level resistance to several once-effective anti-HIV drugs; others have "burned" whole classes of antiretroviral agents.

The following list -- of clinical trials that are open to individuals who have broken through on their current antiretroviral regimen -- offers a range of options to people who have been on therapy for many years, and who have, as an inevitable consequence, been on many therapies. This is a selective listing; for a complete list of clinical trials that are now enrolling treatment-experienced individuals, call 1-800-TRIALS-A.

In conformance with standard practice, we have listed the drugs that are being tested in these trials by their chemical name. For the brand names of these agents, see the box at the bottom of the page. Agents that are still undergoing clinical testing and have yet to win F.D.A. approval, such as MKC-442 and T-20, do not yet have brand names.

THERAPEUTIC OPTIONS FOR PATIENTS WHO BREAK THROUGH
DESPITE ADHERENCE TO THEIR ASSIGNED COMBINATION THERAPY

Drug(s) Being Tested Trial Number Major Inclusion/Exclusion Criteria
ABT-378, efavirenz AD 378 No pregnant or nursing women
PI experience allowed
Amprenavir, indinavir, nelfinavir, lamivudine, abacavir PRO 20005 No prior use of abacavir, amprenavir, or any NNRTI
No hepatitis within 6 months
No currently active OIs
At least 12 weeks prior indinavir or nelfinavir, with increasing viral load
Amprenavir, saquinavir, ritonavir, indinavir, efavirenz, zidovudine, ACTG 400 Prior nelfinavir for at least 16 weeks with increasing viral load
No prior exposure to one of the following combinations: AZT+3TC, lamivudine, stavudine, didanosine d4T+3TC, d4T+ddI, or AZT+ddI Multiple clinical exclusions
No pregnant or nursing women
MKC-442, didanosine, stavudine, nevirapine, hydroxyurea ICC 601 No prior use of d4T, ddI, or any NNRTI
Adefovir, abacavir, efavirenz, amprenavir ICC 605 No prior use of any of the study medications
No prior NNRTI use
Failing PI treatment
Amprenavir, ritonavir, nelfinavir, efavirenz NIH 991 No prior use of abacavir, amprenavir, or efavirenz
No history of intolerance to ritonavir or nelfinavir
No pregnant or nursing women
Several other clinical criteria
Efavirenz, combined nucleoside analogues, ritonavir, saquinavir, nelfinavir, indinavir CPCRA 057 No prior NNRTI experience
No active OIs
No pregnant or nursing women
No vaccination within two weeks
T-20 (pentafuside), amprenavir, abacavir, efavirenz T20-206 No prior treatment with abacavir, amprenavir, efavirenz, or NNRTIs
On a PI for at least 16 weeks
No active OIs
Other clinical criteria
Tipranavir, ritonavir UP-006 Prior experience with 2 or more PIs within 7 months
No pregnant or nursing women
Tipranavir, ritonavir, saquinavir, nucleoside analog UP-0016 Prior PI experience
No prior use of saquinavir or ritonavir
Interleukin-12 vs. placebo ACTG 325 Prior ARV for > 4 weeks
No pregnant or nursing women
CD4 count < 50
Other clinical criteria
Interleukin-2 vs. placebo CPCRA 059 Currently on ARV
No autoimmune disorders
CD4 count > 350
No pregnant or nursing women
Nelfinavir, ritonavir, nevirapine, lamivudine, stavudine, didanosine, zidovudine ACTG 366 Ages between 6 months and 21 years
No serious infections within 2 weeks
No prior use of ritonavir with nelfinavir
No prior pancreatitis or severe peripheral neuropathy
Viral load > 50,000
No pregnant women
Saquinavir, zidovudine, didanosine,  dideoxycitidine, stavudine, lamivudine ACTG 397 Ages between 3 and 16 years
No pregnant or nursing women
No prior treatment with saquinavir and nelfinavir
lodenosine NCI 97-C-0119 Ages between 6 months and 18 years
No active or very recent OI
No history of pancreatitis
Multiple other clinical criteria


Notes:
 • For information about where these studies are offered in the United States, call 1-800-TRIALS-A.
• For more detailed information about any of these studies, call 1-800-TRIALS-A.
• The study drugs listed are all of the drugs that will be tested in the trial. You will not necessarily take all of the drugs listed.
List of abbreviations: PI=protease inhibitor; NNRTI=non-nucleoside reverse-transcriptase inhibitor; OI=opportunistic infection; ARV=antiretroviral
Drug synonyms: AZT=zidovudine=Retrovir; ddI=didanosine=Videx; d4T=stavudine=Zerit; 3TC=lamivudine=Epivir; ddC=dideoxycitidine=Hivid; abacavir=Ziagen; nevirapine=Viramune; delavirdine=Rescriptor; efavirenz=Sustiva; indinavir=Crixivan; ritonavir=Norvir; saquinavir=Fortavase; nelfinavir=Viracept; amprenavir=Agenerase


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 AIDS Care.
 
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