Hecht FM, Levy JA, Martinez-Marino B, Grant RM, McGrath M, Web M, Warmerdam M, Busch MP, Chesney MA, Altfeld M, Walker B, Kahn JO; Conference on Retroviruses and Opportunistic Infections.
Program Abstr 8th Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 8th 2001 Chic Ill. 2001 Feb 4-8; 8: 164 (abstract no. 407).
Univ of California, San Francisco.
Background: We are performing a randomized trial to determine the effects on virologic and immunologic outcomes of using IL-2 together with antiretroviral (ARV) therapy in primary HIV. Methods: Participants are recruited by the UCSF Options Project study and must start on ARV within 12 months of HIV seroconversion. All patients receive ZDV, 3TC, and nelfinavir and are randomized without blinding to receive early (E) IL-2 (within 4 weeks of an HIV-1 RNA <500) or deferred (D) IL-2 (48 weeks after HIV RNA <500). 7.5 mill. U of IL-2 are given SQ twice daily for 5 days every 8 weeks for 6 cycles. Virologic (bDNA 3.0 and quantitative CD8-depleted PBMC co- culture) and immunologic parameters (CD4 count, CTL responses, non-cytotoxic CD8+ HIV suppression, memory and naive CD4 subsets) are measured. Results: We report on 24 patients with > or = 24 weeks of ARV, 11 randomized to E IL-2 and 13 to D IL-2. At baseline, mean CD4 counts were higher by chance in the E than the D IL-2 groups (605 and 428, respectively; P = 0.02, t-test). Mean baseline HIV RNA was lower in the E than the D IL-2 group (4.7 log and 5.3 log, respectively), but this was not statistically significant (P = 0.2, t-test). At week 24 of ARV treatment the mean increase in CD4 count from baseline was 659 in the E IL-2 group and 186 in the D group (P = 0.003). Both memory and naive CD4 cells increased with IL-2. E IL-2 was associated with maintenance of initial CD8+ non-cytotoxic cell suppression. At week 24, HIV RNA was <50 copies/ml in 10/11 patients in the E IL-2 group and 7/ 13 patients in the D group (P = 0.08, Fisher's exact). Titers of replication-competent HIV did not decrease during IL-2 therapy. Conclusions: Patients with primary infection achieve higher CD4 cell counts when IL-2 is added to HAART. There is evidence of improved maintenance of CD8+ non-cytotoxic cell suppression of HIV with IL- 2; CTL studies are being performed. We have not observed decreases in HIV reservoirs, but there was a trend toward more frequent suppression of HIV-1 RNA levels <50 copies/ml by 24 weeks when IL-2 was added to HAART.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Anti-HIV Agents
- Antiretroviral Therapy, Highly Active
- CD4 Lymphocyte Count
- CD4-Positive T-Lymphocytes
- CD8-Positive T-Lymphocytes
- Clinical Trials as Topic
- HIV
- HIV Infections
- HIV Seropositivity
- Humans
- Interleukin-2
- Lamivudine
- T-Lymphocytes, Cytotoxic
- Zidovudine
Other ID:
UI: 102244190
From Meeting Abstracts