A randomised, triple-arm study to compare the viral and immunological outcome of highly active anti-retroviral therapy during six versus 15 months versus no treatment in patients with primary human immunodeficiency virus-1 (HIV 1) infectio

Not Applicable

Completed

• Conditions: Human immunodeficiency virus (HIV), primary human immunodeficiency virus-1 (HIV-1) infection; Infections and Infestations; Immunodeficiency virus

• Registration Number: ISRCTN59497461
• Lead Sponsor: Academic Medical Centre (AMC) (The Netherlands)

Brief Summary

2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22479156 [added 16/01/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-23
• Study Completion: 2012-02-01
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

Diagnosis of acute/recent human immunodeficiency virus-1 (HIV-1) infection: plasma HIV-1 ribonucleic acid (RNA) load detectable and/or detectable serum p24 antigen and one of the following:
1. Enzyme-linked immunosorbent assay (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

Does not comply with the above inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Plasma HIV-1 RNA at week 96:<br> 1. Magnitude of viral set-point will be evaluated for both treatment groups 36 weeks after treatment discontinuation, and a comparison will be made between all groups at week 96 (= study end)<br> 2. Comparison between all three groups of viral kinetics (including rebound) during the off-treatment periods<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. CD4+ cell counts<br> 2. Safety: (serious) adverse events, HIV related events and death<br> 3. Quality of life<br> 4. Time between diagnosis and start/reinitiation of HAART<br> 5. Time between treatment discontinuation and reinitiation of HAART<br><br> In selected groups/individuals:<br> 6. HIV-1 specific CD4+ and CD8+ T-cell response and their state of activation and maturation<br> 7. Humoral immune response parameters<br>