An open randomised trial to evaluate the activity and tolerability of combinations of reverse transcriptase and protease inhibitors, including induction therapy, in individuals with Human Immunodeficiency Virus-1 (HIV-1) infection and CD4 cell counts greater than 25 x 10 to the power of 6 per litre

Completed

• Conditions: Infections and Infestations; Human Immunodeficiency Virus-1 (HIV-1); HIV, Acquired Immunodeficiency Syndrome (AIDS)

• Registration Number: ISRCTN58987964
• Lead Sponsor: Medical Research Council (MRC) (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2000-10-03
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
ot provided at time of registration