Rationale and objective: Interferon alpha (IFN-alpha) has anti-retroviral activity and is a possible HIV infection-limiting factor. The aim of this work is to prevent or delay disease progression in asymptomatic Human Immunodeficiency Virus (HIV) carriers.
Design and interventions: Recombinant IFN alpha-2b (3 x 10(6) IU 3 times weekly) was compared to no treatment (control) in a randomized trial. Endpoints were: (i) appearance of any CDC group IV symptoms and (ii) disease progression (which excluded shifts to group IVC2 or reversible IVA, or IVB). The trial lasted from October 1987 to February 1992.
Setting: The trial was performed at the "Santiago de las Vegas" sanatorium, a specialized institution for the care of HIV-infected and AIDS patients.
Population: Subjects were anti-HIV-1 seropositive, Western blot-confirmed, asymptomatic (CDC group II), or with generalized lymphadenopathies (CDC group III). The groups had 79 (control) and 71 (IFN) patients.
Main results: Long-term IFN-alpha treatments significantly reduced the proportion of patients who shifted to any group IV (control: 46/79; IFN: 14/71; p < 0.001) or developed AIDS (control: 27/79; IFN: 12/71; p < 0.05). IFN also delayed progression to AIDS (95% confidence interval for 0.5 probability of progression) from 67-83 to 116-180 months after infection. The IFN group had significantly less opportunistic infections and non-infectious complications. CD4 cell count and hemoglobin decreased in the control but not in the IFN group. Fewer IFN-treated patients developed positive serum HIV antigen detection.
Conclusion: IFN alpha treatment during the early stages of infection seems to be beneficial to the patients.