Human Immunodeficiency Virus (HIV), Acquired Immunodeficiency Syndrome (AIDS) Infections and Infestations Human Immunodeficiency Virus (HIV), Acquired Immunodeficiency Syndrome (AIDS)
Conditions
Interventions
Three different 2-drug nucleoside analogue reverse transcriptase inhibitors (NRTI) combinations in children taking either nelfinavir (NFV) or nelfinavir (NFV) placebo
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. 3 months to 16 years of age 2. Definitive HIV-1 infection
Exclusion criteria
Exclusion criteria: Not provided at time of registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 2. To compare two different viral load criteria for switching from first-line to second-line therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate and compare the safety and tolerability of each drug combination (including first- and second-line therapies) 2. To compare the long-term clinical and immunologic outcomes (by the initial randomization) 3. To compare the proportions of children who have undergone one regimen switch or reached study end-point (by the initial randomization) 4. To compare time from randomization to virologic failure (RNA >400 copies/ml at or after week 24) of the first-line therapy analyzed by initial randomization to either protease inhibitor (PI) or NNRTI containing regimens 5. To compare time from randomization to virologic failure of the second line therapy (RNA >30,000 copies/ml) analyzed by the initial randomization 6. To compare the proportion of children with plasma HIV-1 RNA <400 copies/ml at 4 years (by the initial randomization) 7. To describe resistance patterns at 4 years (by the initial randomization) | — |
Countries
England, United Kingdom
Outcome results
None listed