United Press International - Wednesday, November 18, 1998
Ed Susman

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said, "This would be the proof of the pudding."

The proposal follows new studies announced Sunday showing HIV was eliminated from the blood of three infected patients. That success, he said, sets the stage for studies to determine if clearing the blood of HIV means the patient has cleared his body of the virus as well.

On Sunday, at the Infectious Diseases Society of America meeting in Denver, Fauci said that after scrutinizing more than 300 million immune system cells no virus could be detected in the blood of three patients.

Based on that success, researchers have designed the unique study.

Fauci told UPI today, "We have a written a protocol in which patients who have no sign of virus in the blood would have their medication withdrawn to see if the virus will continue to be suppressed. " Still, he said, "I personally believe the virus will come back."

He said the virus could be lurking in "persistent, recalcitrant reservoirs in the body" -- the lymph system, including hard to access gut-associated lymph tissue, the spinal fluid, the brain and the reproductive system.

For three years, AIDS researchers have been using highly active antiretroviral therapy (HAART) -- combinations of AIDS drugs -- to dramatically lower the amount of circulating virus in the blood. Some AIDS patients have hundreds of thousands to millions of copies of the virus in each milliliter of blood.

Three years ago, doctors were thrilled if patients circulating virus dipped to undetectable levels. At that, the tests stopped reporting virus below 10,000 copies per ml. Newer tests have a 400 copy cutoff, and still experimental tests have cutoff of 50 cells and less. In one patient, a single viral cell was found after searching through 60 million immune system cells.

Fauci's patients did not show virus after examination of 300 million such cells.

"We couldn't find the virus in the blood of these patients," Fauci said. "We couldn't find it in the blood at all. This could be a step towards eradication of the virus. But we can only say that we have eliminated the virus from the blood. We cannot say we have eradicated the virus from the body."

That's one of the major caveats of these studies," Fauci emphasized. "We only know we've been able to get rid of the virus from the blood. We don't know if that is enough to keep the virus suppressed once the HAART regimen is withdrawn."

In a handful of cases, doctors and patients have tested the theory that by driving the virus below detectable levels, the virus cannot replicate. In most of these cases, the virus has rebounded.

Fauci said, "A couple of years ago I wouldn't have even considered taking patients off medication. "Now," Fauci told UPI, "we have so many good drugs available that I think we could use another regimen of drugs to put a patient back into re-suppression of virus if there was a rebound."

Despite the risks, Fauci said patients are willing to stop taking medication and test the theory that eradicating HIV virus from the blood is sufficient to prevent re-emergence of the infection. Although the HAART regimen has been successful in driving down the levels of virus in the blood, there are serious side effects associated with the treatments, including diabetes, kidney stones and development of unsightly fat deposits on the back, shoulder and abdomen.

In Fauci's studies, the immune enhancer Interleukin-2 (IL-2) was added to patients taking a combination of drugs that make up the HAART regimen. He began treating patients with the HAART plus IL-2 combination early this year with a treatment that continued for several week. Fauci said the therapy did not work consistently in the 14 men who received active treatment.

Although in six of the men, no HIV could be detected in up to 20 million copies of immune system cells. In three of the six, no HIV was found in 300 million immune cells. In one patient, HIV traces could not be detected in a biopsy of his lymph node tissue, either. In 12 other HIV-infected men who did not receive IL-2, HIV-infected immune system cells were detected at the end of the study.

Other attempts to eliminate the virus are underway around the world, some using the anticancer drug hydroxyurea along with HAART to try to get at the latent AIDS virus in the body.

Fauci said, "We are all aiming for the same goal, but the mechanisms of action are different." He said he isn't sure if his use of IL-2 flushes out the virus from its hiding places or enhances the immune system in AIDS patients to destroy the pockets of virus.

"The take-home message from our work reported at the IDSA meeting," Fauci said, "is that we have made a step in the direction of eradicating the latently-affected pools of HIV in the body."

Fauci said his comments were filled with caveats because: "I'm very uncomfortable in saying that we have eradicated the virus. I would not be surprised if the virus comes back in patients if we stop medication."

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