Long-term follow-up of HIV-1-infected Thai patients immunized with Remune monotherapy.

Abstract

PURPOSE:

The purpose of this 2-year follow-up study was to investigate the long-term effect of Remune as monotherapy for HIV-1 infection.

BACKGROUND:

Participants previously enrolled in the phase II double-blind, randomized, adjuvant-controlled study of the HIV-1 Immunogen (Remune) were followed for 2 years. Open-label immunization with Remune monotherapy was given to each participant every 12 weeks. Remune, a gp 120-depleted HIV-1 that was inactivated in beta-propiolactone and irradiation, was emulsified with mineral oil (incomplete Freund's adjuvant).

METHOD:

In Study 2101B, the effect of four doses of Remune given every 12 weeks over 40 weeks was compared to placebo in 297 asymptomatic type E HIV-infected patients [Churdboonchart et al., 2000]. A group of 17 volunteers were separated into a subset study and another 57 were excluded from analysis due to discontinuation or addition of other treatments. This 2-year follow-up study continued with open-label dosing of HIV-1 Immunogen every 12 weeks for the remaining 223 patients. Changes in CD4+ cells, CD8+ cells, and body weight were monitored at each patient visit.

RESULTS:

Overall, immunizations were safe; common adverse events were tolerable injection site reactions. CD4+ T-cell counts remained stable over the 132-week observation period for this cohort with a slight increase of 36.01 cells/microL. CD8+ T-cell counts showed an increase from baseline during the follow-up period (415.21 cells/microL). Furthermore, we also observed an increase in body weight from baseline (1.08 kg) at week 132. In addition, baseline CD4 count appeared to predict CD4 count at week 132 (slope = 0.31, p <.0001).

CONCLUSION:

These results suggest that long-term treatment of HIV-1 infection with Remune monotherapy is safe and results in a stabilization of CD4+ counts. Furthermore, it is likely that HIV-1 therapeutic immunization may show its greatest clinical benefit in participants with higher CD4+ cell counts. Such an approach may have important ramifications in developing countries where access to antiviral drugs is limited and also in early chronic HIV-1 infection when CD4+ cells are still over 300 cells/microL in order to limit the cost and toxicity.

• Authors: W Sukeepaisarncharoen, V Churdboonchart, S Kulpradist, B Isarangkura Na Ayudthya, S Rugpao, V Chandeying, W Sirawaraporn, D Carlo, R B Moss
• Journal: HIV clinical trials (HIV Clin Trials) 2001 Sep-Oct Vol. 2 Issue 5 Pg. 391-8 ISSN: 1528-4336 [Print] England
• PMID: 11673813 (Publication Type: Clinical Trial, Comparative Study, Controlled Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• AIDS Vaccines
• Vaccines, Subunit
• remune

Topics

• AIDS Vaccines (therapeutic use)
• Body Weight
• CD4 Lymphocyte Count
• CD8-Positive T-Lymphocytes (immunology)
• Cohort Studies
• Female
• Follow-Up Studies
• HIV Infections (diagnosis, immunology, therapy)
• HIV-1 (immunology)
• Humans
• Lymphocyte Count
• Male
• Regression Analysis
• Thailand
• Vaccines, Subunit