AEGiS-14IAC: Structured Treatment Interruptions (STI) in patients receiving HAART within 90 days after onset of Primary HIV-1 Infection (PHI) symptoms: spontaneous control of viremia in only one third of cases after four cycles off therapy.

14th International AIDS Conference

Barcelona, Spain - July 7-12, 2002

Structured Treatment Interruptions (STI) in patients receiving HAART within 90 days after onset of Primary HIV-1 Infection (PHI) symptoms: spontaneous control of viremia in only one third of cases after four cycles off therapy.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. ThOrB1437)

Miro JM, Plana M, Garcia F, Ortiz GM, Maleno MJ, Arnedo M, Rio AD, Claramonte X, Garcia A, Joseph J, Pumarola T, Nixon D, Gallart T, Gatell JM
H. Clinic - Idibaps, Barcelona, Spain

Bakground: To analyze if four cycles of STI can restore HIV-1 specific T-cell responses (CD4+ and CTL) and control HIV-1 replication in patients who started HAART within 90 days after onset of PHI symptoms.

METHODS: 12 consecutive patients with sustained viral suppression (<20 copies/mL) and a CD4+/CD8+ ratio >1 after d4T, 3TC&indinavir for at least 1 year since PHI were included in an STI program (4 cycles of 2 months off therapy and 2-4 months on HAART).

RESULTS: 8 patients were homosexual men. Median age was 34 years. Median (range) plasma viral load (PVL) at PHI was 134,500 copies/mL (3,215->1,000,000). After a median (range) of 23 months (12-45) of HAART, all but one patient had plasma and tonsil tissue VL <5 copies/mL or <40 copies/mg respectively. Median (range) CD4+T cell count = 927 (613-1,648) cells/mm³. Median (range) TREC CD4+/10(6) T cells = 978 (249-2880). None of 12 patients had HIV-1-specific CD4+ (LPR) T-cell responses before first stop. The number of patients who completed the 1st, 2nd, 3rd and 4th cycles = 12, 12, 12 and 6 cases, respectively. During the 1st, 2nd, 3rd and 4th period off therapy, mean (SD) PVL rebound = 4.89 (0.7), 3.89 (1), 4.04 (1.6) & 3.48 (1.8) log₁₀/mL and PVL rebound remained <3,000 copies/mL in 0/12, 4/12, 4/12 & 2/6 cases, respectively. There was no correlation between the level of TRECs and the type of virological response. HIV-1 specific CD4+ LPR responses were detected in 5/12, 6/12, 7/12 and 2/6 cases during each period off therapy, respectively. A weak CTL response (ELISPOT) was detected at baseline in 6 out of 12 patients. The magnitude of the CTL response increased after each cycle off therapy. No genotypic resistance to antiretrovirals was found.

CONCLUSIONS: HIV-1 specific T-cell responses can be restored using STI in patients receiving HAART within 90 days after PHI. However, a spontaneous control of viremia (<3,000 copies/mL) was found in only one third of cases.

Keywords: AEGIS, Antiretroviral Therapy, Highly Active, Viremia, HIV Infections, Viral Load, HIV-1, CD4 Lymphocyte Count, Virus Replication, T-Lymphocytes, Drug Therapy, Combination, Human, Male, therapy, Diagnosis, virology, drug therapy

020707
ThOrB1437