Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
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AIDS TREATMENT NEWS Issue #300, August 7, 1998
John S. James
This trial is open to persons who currently have a CD4 count of over 500, and who either are on antiretroviral treatment already, or are willing to begin treatment. All study medications will be paid for while the patient is in the trial, which will last up to 18 months. In addition to the antiretroviral treatment, there will be six injections of the vaccine during a period of one year. NIH will pay for transportation (except for the first trip), so volunteers do not need to live in the Washington D.C. area.
Volunteers must never have had a CD4 count under 300, unless the low count occurred during acute HIV infection.
The vaccine being tested consists of two HIV peptides of the viral envelope, including the V3 loop. This is the first trial in which these peptides together will be given to humans. Each has been tested separately in a few people, however (without the antiretroviral therapy), and no adverse effects have been seen.
Intensive immunologic studies will be performed to see whether HIV-specific responses--especially T-helper, cytotoxic T lymphocyte (CTL), and neutralizing antibody responses--can be restored by this vaccination while the virus is being suppressed by the drugs. Such effects on HIV- specific immunity have already been found in animal tests, and some have been seen in the early human tests with the peptides, even without the antiretroviral treatment.
Comment
Interest is growing rapidly in finding ways to restore HIV- specific immune responses, which are usually lost very early in the infection. A similar study, but using a different vaccine, reported strikingly successful results at the recent 12th World AIDS Conference in Geneva (abstract #31227, late breaker session #LB 9; see report in AIDS TREATMENT NEWS #298, July 10, 1998).
These HIV-specific responses are maintained naturally by long-term nonprogressors, but are lost by the great majority of patients, who do progress to HIV disease. There is no data yet on whether restoring these responses by treatment is clinically beneficial.
For More Information
For more information about volunteering for this study, contact either Tino Merced-Galindez, R.N. (800-772-5464 ext. 562, or 301-496-8959, or merced@box-m.nih.gov), or Richard Little, M.D. (800-772-5464 ext. 657, or rlittle@helix.nih.gov), at the HIV and AIDS Malignancy Branch, National Cancer Institute.
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