HIV-1 infection Infections and Infestations Human immunodeficiency virus (HIV)
Conditions
Interventions
Randomisation of approximately 1000 participants, from 17 countries worldwide, to one of three drug regimens:
1. 2 NRTIs plus a NNRTI
2. 2 NRTIs plus a PI
3. 2 NRTIs plus a NNRTI and PI
Quality of li
Sponsors
Medical Research Council (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The participants in the trial must be HIV-1 infected, over 18 years of age, at any stage of HIV disease, but not acute symptomatic primary infection, where anti-retroviral therapy is indicated. Participants should be likely to take their first regimen for at least 6 months and be expected to adhere to the protocol.
Exclusion criteria
Exclusion criteria: 1. The participants must not have received prior treatment with antiretroviral drugs or immunotherapy 2. There must be no history of peripheral neuropathy or pancreatitis 3. Individuals must not be receiving combination cytotoxic chemotherapy for cancer or parental therapy for an active opportunistic infection 4. Women should not be pregnant, breastfeeding or unwilling to use adequate contraception 5. Participants will be ineligible if biochemistry and haematology blood results from screening are outside the trial upper safety limits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in CD4 cell count between 2 and 3 years 2. The proportion of patients with plasma HIV RNA below 50 copies/ml at 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in CD4 cell count between 2 and 3 years 2. Change in plasma HIV RNA at 3 years 3. The time on first regimen 4. Time on second regimen (where applicable) 5. The time to first plasma HIV RNA below 50 copies/ml 6. Phenotypic and genotypic drug resistance at 3 years 7. Progression of HIV disease (including death) | — |
Countries
Australia, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, New Zealand, Portugal, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed