HIV, Acquired Immunodeficiency Syndrome (AIDS) Infections and Infestations Human Immunodeficiency Virus-1 (HIV-1)
Conditions
Interventions
1. Didanosine (ddI), Stavudine (d4T), Nevirapine (NVP) plus Nelfinavir (NFV) for at least 24 weeks, then ddI, d4T and NVP as maintenance therapy
2. Continuous ddI, d4T plus NVP
Note: third arm with
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 years or more with documented HIV-1 infection and requiring anti-retroviral therapy 2. CD4 count greater than 25 x 10 to the power of 6 per litre 3. Any stage of HIV disease including recent infection (except acute symptomatic primary infection) 4. Likely to survive at least 2 years and take the allocated therapy for at least 6 months 5. Able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Previous anti-retroviral treatment or immunotherapies 2. Peripheral nephropathy or a history of pancreatitis 3. Women who are pregnant, breastfeeding or not taking adequate contraception 4. Heterosexual men not willing to use barrier contraception 5. Receiving combination chemotherapy for cancer 6. Receiving parenteral therapy for an opportunistic infection 7. Unlikely to comply with the protocol 8. At screening with creatinine above upper limit of normal (ULN), ALT or AST above 2.5 times ULN, amylase above 1.5 times ULN (except if pancreatic amylase less than 1.5 times ULN), haemoglobin less than 10.5g/dl, neutrophils less than 1.0 or platelets less than 100
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Virological failure defined as failure to achieve plasma HIV RNA less than 50 copies per millilitre during the first 24 weeks or, having achieved such a level of suppression, subsequent rebound of plasma HIV RNA above 400 copies per millilitre. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed