A randomised phase II trial to compare the toxicity, tolerability and activity of 2-drug combinations of the nucleoside analogue reverse transcriptase inhibitors (NRTIs) lamivudine ((-)2'-deoxy-3'thiacytidine, 3tc), zidovudine (ZDV) and 1592U89
- Conditions
- Human Immunodeficiency Virus (HIV), Acquired Immunodeficiency Syndrome (AIDS)Infections and Infestations
- Registration Number
- ISRCTN31541725
- Lead Sponsor
- Medical Research Council (MRC) (UK)
- Brief Summary
2000 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/10776748 2001 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/11531953 2002 Results article in http://www.ncbi.nlm.nih.gov/pubmed/11888583 2002 Results article in http://www.ncbi.nlm.nih.gov/pubmed/12134227 2002 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/12351958 2003 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/12544410 Adherence to prescribed antiretroviral therapy 2007 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/17457088 5 year follow up
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
1. 3 months to 16 years of age
2. Definitive HIV-1 infection
Not provided at time of registration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. To compare the combination of two NRTIs plus a protease inhibitor (PI) versus two NRTIs plus a non-nucleoside reverse transcriptase inhibitor (NNRTI) as initial therapy, followed by second-line therapy if virologic failure occurs, in terms of their effects on a long-term virologic endpoint<br> 2. To compare two different viral load criteria for switching from first-line to second-line therapy<br>
- Secondary Outcome Measures
Name Time Method