The Bay Area Reporter - July 27, 2000
Matt Sharp, Survive AIDS Writers Pool

The Berlin patient was the catalyst for research into stopping HIV drugs and then restarting them. Called strategic therapy interruptions (STI), or structured intermittent treatment (SIT), the concept is basically about stopping HIV therapy for awhile, then restarting it, hoping for a lowering of viral load, possibly not having to take as many drugs, or never having to take them again. There is also hope that this strategy will rebuild important immune system cells. It is the buzz in HIV research today studied mostly in two populations of people: those who have not taken drugs before and have higher T-cells, and those who have been on many rounds of HIV therapy and have fewer T-cells.

Dr. Keith Henry from University of Minnesota said that 22 percent of his patients were interrupting treatment for various reasons. The Berlin patient and other people with HIV are the driving force behind this strategy simply because of the dire realities of having to continue taking so many drugs that may not remain effective or may have toxic side effects. Martin Delaney, founder of Project Inform stated recently, "Can people stay on these drugs for a lifetime? Probably not." It is common knowledge that people are getting weary of taking medications, because of the sheer number of pills and doses, and because of toxic side effects.

Early on in the research scientists were afraid that stopping or interrupting therapy at any time would cause the virus to mutate. However, while resistance does appear in many people it doesn't seem to be effecting the outcome one way or the other in the preliminary data from Durban and elsewhere. Most studies presented are still all over the map and answers remain illusive. The answer one gets when inquiring about the STI is "it's working for some people, but not for others."

Even with the insufficient studies, there are important reasons for the research to continue. Not only is there excitement about the possibility of reducing the pill burden in order to reduce drug toxicity, but there are major implications with cost savings in developing countries, ADAP, and MediCal programs.

The stress of the AIDS pandemic on developing countries' infrastructure and economy are nothing short of a disaster. Besides the fact that people with AIDS are demanding the drugs, horrifying epidemiological statistics point to a real good reason for reducing the amount of drugs required for treatment. One study presented by Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, depicts a strategy of going on and off drugs every seven days. While the data is only on eight people at 14 weeks, no one has gone above the 500 viral load limit of detection, except one patient who forgot to take the medication. This strategy would reduce pill burden by half.

Based on these new findings, Fauci is encouraging NIAID researchers to develop new studies looking at structured interruption. Two NIAID AIDS research programs, the CPCRA (Community Programs for Clinical Research on AIDS) and the ACTG (AIDS Clinical Trials Group) are developing new studies as well. Researchers Dr. Steven Deeks at the University of California, San Francisco and Dr, Jeff Harris at the Gladstone Institute are also recruiting for studies. Other studies are investigating as well (see box below).

But while institutional researchers plod along, taking precious time designing protocols and fighting for funding, and pharmaceutical companies balk at STI studies because of how this strategy may effect profit, the HIV community has once again stepped forward to drive the effort. AIDS activists Hank Wilson and Matt Chappell from Survive AIDS are developing a project to collect anecdotes of people stopping and starting their HIV treatments.

Realizing that an enormous amount of data could be gathered on the growing number of people who were going off therapy for a variety of reasons, Wilson became increasingly frustrated at the slow pace of the research. He stated, "Our goal is that we want people to tell us their stories, we will re-contact them and follow them over time, and then contextualize what people are doing. This is basically patients who are science in the making."

Wilson continued, "We don't know if this will work, but the project could become the biggest cohort in the country. We already have more patients than Fauci presented in Durban, which was basically anecdotal too. We're not pretending that we know, but treatment interruption is the most hopeful news since protease inhibitors."

Wilson admits that collecting anecdotal information is not as effective as a controlled study, but that something can be learned from analyzing information from thousands of people. Also, a project such as this can only forge the research ahead and spawn excitement with scientists, funders and patients.

Funded exclusively by Survive AIDS, Wilson stated that the effort is driven by technology. "We are developing a database and an online survey so that we can hear from people all over the world who are stopping therapy. How do we know what the right way and wrong way is to go about this strategy if we don't ask the questions and collect the data?"

So, given the dramatic need for something to be done about the complexity, expense and hassle of HIV treatment, it is not surprising that this promising new strategy of looking at other ways to fight AIDS is being spearheaded by people with HIV while research institutions move their studies ahead.

Treatment interruption studies in the Bay Area

The following is information on local STI studies:

* Gladstone Institute of Virology

Contact Diane Schmidt (415) 695-3820

Requirements: Never have been below 100 CD4 cells, and less than 50 viral load, but must have been above 20,000 copies any time prior to starting the current Host commonly cited factors thatnical Research Center

Contact Becky Hoh (415) 476-3669, ext. 1

Requirements: Less than 300 CD4 cells, and more than 5,000 viral load in the last six months, must be taking a protease inhibitor.

* Community Programs for Clinical Research on AIDS

Contact Mike Jones (415) 476-9554, ext. 35

Requirements: Randomized treatment interruption study based on resistance testing, no CD4 cut off requirement, viral load 10,000 or above, must be on antiretroviral treatment.
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