Six new clinical trials have recently begun in the UK.
ERA (Evaluation of Resistance Assays) is a comparison of different resistance testing strategies in people. Group A is for participants who have not taken many anti-HIV drugs in the past and are thus more able to choose an effective 3-drug regimen without a resistance test. Participants in this group will be randomly assigned to either select their new drugs without a resistance test or to receive a genotypic resistance test at the beginning of the study.
Group B is for participants for whom an effective 3-drug regimen cannot be selected. All participants in this group will receive a genotypic test at the beginning of the study and whenever their treatment might need changing. They will also be randomly allocated to also receive or not receive a phenotypic test. This mans there will be two arms in this part of the study:
- genotypic test but no phenotypic test
- phenotypic test and genotypic test
To join the trial, you must be currently receiving antiretroviral therapy with evidence of virological failure, have a viral load over 2000 copies, and wish to change your treatment if treatment failure is confirmed.
Tenofovir DF, (formerly known as PMPA), is an investigational nucleotide analogue in development by Gilead Sciences, who are also responsible for the similar drug, adefovir. Study GS-99-907 is designed for people who are currently receiving stable antiretroviral therapy with a maximum of four licensed drugs, with viral rebound between 400 and 10,000 copies. Participants will be randomised to receive a once daily dose of tenofovir, or a placebo, for 24 weeks. After this time, everyone in the study will receive tenofovir for 24 weeks. After 48 weeks, all participants will be offered continued access to tenofovir. This study is recruiting at sites in Brighton and London. A second study, protocol 903, designed to evaluate the safety and efficacy of tenofovir in people who have not yet started antiretroviral treatment is currently being finalised.
Trizivir is a combination of three Glaxo-Wellcome nucleoside analogues (abacavir, 3TC and AZT) that is taken as one tablet twice daily. The TRIZAL study is designed to compare the efficacy and durability of response in people who switch to Trizivir with that in people who remain on their current treatment. Treatment will be allocated at random, and will be open-label, meaning participants will know which treatment they are taking. The trial will last for 48 weeks, and is recruiting volunteers who have been taking triple antiretroviral therapy for at least six months, who have viral load between 50 and 400 copies, and a CD4 count above 100. Trial sites are in Brighton, London, Manchester and Sheffield.
BMS-232632 is a new protease inhibitor from Bristol-Myers Squibb. Protocol AI424-009 is currently recruiting 75 people who have been taking an antiretroviral regimen containing a protease inhibitor for at least twelve weeks, and have viral load between 2,000 and 10,000 copies. Participants will receive either:
- BMS-232632 (400mg once a day) plus saquinavir (1200mg once a day) plus two of either ddI, 3TC, d4T or AZT
- BMS-232632 (600mg once a day) plus saquinavir (1200mg once a day) plus two of either ddI, 3TC, d4T or AZT
- ritonavir plus saquinavir twice a day plus two of either ddI, 3TC, d4T or AZT.
Safety and activity of the regimens will be assessed after four weeks of therapy. Any dosing group found to be inferior in antiviral activity will then be dropped. In stage 2, enrolment will re-open and 300 more participants will be divided into the remaining treatment groups. The trial will last for 48 weeks. Participants must not have prior exposure to at least one of the following nucleoside combinations: d4T/ddI, d4T/3TC, AZT/3TC, ddI/AZT. This study is recruiting at the Chelsea and Westminster and at the Royal Free Hospitals.
SU5416 is a new drug believed to have some effect on the growth of AIDS-related Kaposi's Sarcoma cells and tumour tissue, and works by slowing down the development of new blood vessels, thus preventing lesion growth. Study SE5416-301 aims to evaluate the anti-tumour effect of SU5416, and its safety and tolerability in people who have Kaposi's Sarcoma that has not responded to at least two standard therapies, and who have been on stable antiretroviral therapy for at least two weeks. All participants will receive the same fixed dosage of SU5416 by intravenous infusion twice weekly over a period of eight weeks (two cycles of four weeks), with an interim assessment after four weeks. Any patient responding well to treatment will be permitted to continue receiving treatment in further four weeks cycles, up to a maximum of one year in all. This study is recruiting at the Chelsea and Westminster Hospital.
A study designed to compare the efficacy of nevirapine or efavirenz alone, or as dual NNRTIs, in combination with d4T and 3TC, known as protocol 2NN, has begun recruiting naïve patients at sites in Brighton, London and Manchester. Participants must have viral load above 5,000 copies. The study will last 48 weeks and treatment is open-label.