Assessment of Cytokine Values in Serum and by RT-PCR in HIV-1 Individuals With and Without HAART
|ClinicalTrials.gov Identifier: NCT00746473|
Recruitment Status : Completed
First Posted : September 4, 2008
Last Update Posted : September 4, 2008
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||73 participants|
|Official Title:||Assessment of Cytokine Values in Serum and by Specific cDNA Amplification and Detection Using RT-PCR in HIV-1 Infected Individuals With and Without Highly Active Anti-Retroviral Therapy (HAART)|
|Study Start Date :||August 2004|
|Actual Study Completion Date :||October 2005|
15 HIV-1 infected individuals, with or without AIDS, who had never received ARV. These patients had not yet been indicated for ARV, or had had HIV-1 infection diagnosed a few days before inclusion in this study.
27 HIV-1 infected individuals, sick or not, on ARV treatment, five with two nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) and one nonnucleoside reverse transcriptase inhibitor (NNRTI), and 22 on HAART with two NRTI, or one NRTI and one NNRTI, and one protease inhibitor (PI), and VL equal to or greater than 50 copies of plasma RNA/mL.
Treatment duration in this group varied between three and 145 months (mean 53.62 months; median 42 months).
31 HIV-1 infected individuals on ARV treatment, 16 on HAART with two NRTI, or one NRTI and one NNRTI, and one PI, and 15 with two NRTI and one NNRTI. All G3 patients had undetectable VL for at least the past 6 months. Treatment in this group varied between five to 108 months (mean 48.13 months; median 42 months).
20 blood donors without clinical complaints and negative for anti-HIV-1/2 antibodies. None of them showed any sign of disease.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746473
|SAE e Hospital Dia de Aids|
|Botucatu, São Paulo, Brazil|
|Principal Investigator:||Domingos A Meira, PhD, MD||Faculdade de Medicina de Botucatu, Unesp|