The Bay Area Reporter - February 9, 1998
Mike Donnelly, ACT UP/Golden Gate Writers Pool

Many people who are taking protease inhibitors have experienced a rebound in their CD4 counts and are in a quandary about whether to continue prophylaxis. The question is: If the new T-cells are functioning against the diseases, is taking medications to prevent the disease necessary? Since the advent of prophylactic agents, there have been great reductions in deaths. Now with widespread protease inhibitor use, the death rate for people with AIDS has plummeted even further. These opportunistic infections have killed people with AIDS in great numbers in the past, and the threat lingers. There is the desire in both the research and infected communities to know whether OI prophylaxis is still needed.

Current research

There are currently two federally-funded clinical trials sponsored by the AIDS Clinical Trials Group (ACTG) and the Community Programs for Clinical Research on AIDS (CPCRA) to look at discontinuance of MAC prophylaxis. The antibiotics rifabutin, clarithromycin, and azithromycin have been used to prevent MAC.

ACTG 362 is enrolling at two sites locally, Stanford and UCSF. The total number of participants nationally will be 636.

CPCRA 048, with a nationwide accrual target of 850, is currently being enrolled through the Community Consortium with sites at primary care facilities (your doctor's office) throughout the Bay Area. Both studies are quite similar administering azithromycin (1200 mg. once a week) or placebo (sugar pill) for 18 months duration, using the same T-cell criterion, greater than 100. The objective of these trials is to compare the numbers of people developing MAC in each group.

Additionally, the CPCRA trial builds bacterial pneumonia into its primary purpose. "We decided to also look at bacterial pneumonia as it is an often neglected entity in HIV disease," says Dr. Wafaa El-Sadr of Harlem AIDS Treatment Group and Protocol Chair of CPCRA 048.

Two sides to every coin

As with everything in AIDS, there are differing opinions regarding participation in the trial about MAC prophylaxis. We spoke to two of them. Both these individuals fit the criteria for the study, having had a CD4 count of zero sometime in their past, and both have experienced a CD4 rebound due to triple or quadruple antiviral drug regimens.

Neil M., a member of a local community advisory board, reflects, "Since I have felt better, I haven't wanted to change a thing. I should be dead. I'm not really sure what has kept me alive, so I hesitate to change any part of my drug regimen. I take 70 pills a day, so losing two pills a week is no big deal." Neil's CD4 count has risen to 360.

Scott, a person with AIDS, whose CD4s are currently 380, said, "At first, I was sure I wouldn't participate, but now I am in the study. I need to know if my body is responding to the antiviral therapy. I want to know if my body is stronger and doesn't need the crutch of prophylactic drugs. Also, I will get monitored in the study."

Claire Rappoport, the Community Constituency Group (CCG) representative to the Complications of HIV Committee of the CPCRA, notes the importance of these trials: "The question of whether to discontinue prophylaxis for MAC is very important. The results of these studies most likely will have implications regarding the changing standard of care for PCP, CMV, and possibly other OIs."

There is a substudy of ACTG 362, which addresses the discontinuation of PCP prophylaxis. A smaller group (100 of the 636 participants) who have had CD4 rebounds above 200 may also elect to discontinue their PCP prophylaxis, provided that they have never had this infection. Enrollment in this substudy currently poses a problem: only five of 156 participants enrolled in ACTG 362 have co-enrolled. There is concern among both the community and researchers that the trial may not reach the enrollment numbers necessary to answer the question. Co-enrollment can happen at any time during the study, not necessarily upon entry.

Because of the importance of the question, the CPCRA has designed a separate study to answer the PCP prophylaxis question. This study should begin enrolling in the near future.

Jeff Gustavson, the CCG representative of the ACTG to the Therapeutic Immunology Subcommittee, stresses, "While it is clear that the second phase of CD4 rise is attributable to naïve [new] cell generation, the random gene rearrangement that these cells have undergone may not yield the specific immunity necessary to prevent a given OI. In other words, it's a crap shoot."

As more and more people's CD4 counts rebound and move out of the range of danger with respect to OIs, these questions become increasingly important. We need to have studies determining if it is safe to remove prophylaxes in a controlled environment. Many people are choosing to do this on their own, and we are losing the ability to capture data crucial to answering this question.

If you want to participate in these important trials, please call one of the following sites. For ACTG trials, contact Sandy Valle at Stanford University (650) 723-8169, or Matt Sharp at San Francisco General Hospital (415) 476-9296 x 360. For information regarding the CPCRA trial, contact the Community Consortium (415) 502-0658. Both studies reimburse participants $20 per visit.
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