A randomized, triple-arm study to compare the viral and immunological outcome of HAART during 6 versus 15 months versus no treatment in patients with primary HIV 1 infection.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20081

Enrollment

173

Registered

2005-08-17

Start date

2003-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

6 or 15 months of highly-active antiretroviral therapy (HAART) initiated during primary HIV-1 infection.

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of acute/ recent HIV-1 infection: plasma HIV-1 RNA load detectable and/or detectable serum p24 antigen and one of the following: 1. ELISA: HIV-1 specific antibodies negative; or 2. ELISA: low level antibodies or HIV-1 specific antibodies positive and a negative, incomplete or indeterminate Western Blot (antibodies against a maximum of three of the HIV specific proteins); or 3. ELISA: HIV-1 specific antibodies positive and positive Western Blot, but with documented negative HIV-1 ELISA in the preceding 180 days.

Exclusion criteria

Exclusion criteria: 1. Previous test result with HIV-1 RNA detectable or P24 antigen positive > 180 days before presentation; 2. For female subjects: pregnancy (positive urine pregnancy test) or breast feeding.

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of 6 or 15 months of treatment with a quadruple combination of HAART versus no treatment in PHI. Efficacy will be evaluated by: 1. the viral set-point reached for the three groups and viral rebound kinetics after treatment discontinuation for the two treatment groups. 2. the time that patients can remain off therapy after treatment discontinuation.	—

Secondary

Measure	Time frame
To evaluate: 1. the effect of treatment on plasma viral load and CD4+ T cells. 2. the effect of no treatment versus a treatment duration of 6 versus 15 months on the kinetics of HIV-1 specific CD4+ and CD8+ T-cell responses and their state of maturation, activation and proliferative capacity. 3. the development and efficacy of the humoral immune response. 4. the quality of life.	—

Contacts

Public ContactJ.M.A. Lange

Academic Medical Center (AMC), P.O. Box 22660

j.lange@amc.uva.nl+31 (0)20 5667868

Outcome results