Human immunodeficiency virus (HIV) Infections and Infestations Virus
Conditions
Interventions
Participants will be randomly allocated in a 1:1:1 ratio at trial entry to start one of the regimens of open treatment with:
Arm A: Long course Combination AntiRetroviral Therapy (LCART) for 48 week
Sponsors
Imperial College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of both sexes will be eligible for screening if they: 1. Have reached the age of consent in their country for participating in a clinical study 2. Are confirmed PHI by at least one of following criteria: a. HIV positive antibody test within six-months of an HIV negative antibody test (randomisation must take place within six months of previous negative test) b. HIV antibody negative with positive Reverse Transcription Polymerase Chain Reaction (RT-PCR) c. Test 'incident' at low level (less than 0.6) using detuned assay (must be subtype B) d. Equivocal HIV antibody test supported by a repeat test within a two-week period showing a rising optical density e. Have clinical manifestations of symptomatic HIV seroconversion illness supported by antigen positivity and less than four bands positive on Western Blot 3. Able and willing to give written informed consent
Exclusion criteria
Exclusion criteria: Patients will not be eligible for screening if: 1. Pregnant 2. Unlikely to comply with protocol, and in particular adhere to therapeutic regimen 3. Likely to use narcotics during the study period 4. Antiretroviral therapy is indicated 5. Antiretroviral therapy is contraindicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to CD4 cell count less than 350 cells/l (excluding counts in the first three months after diagnosis) on two consecutive occasions not more than four weeks apart. Intervention at PHI is termed PTX (primary treatment) to distinguish it from late treatment (LTX), which may be administered according to local HIV treatment guidelines when indicated. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. HIV-specific CD4+ and CD8+ T-cell responses at week 60 2. Slope of CD4 decline 3. Time from randomisation to virological failure of first regimen of late treatment (LTX) or death 4. Development of drug resistance not present at baseline, before starting LTX or at week 120 whichever is earlier 5. Development of an AutoImmune Deficiency Syndrome (AIDS) defining illness or death 6. Time from randomisation to the initiation of late treatment (LTX) 7. Differences in blood pressure from randomisation at week 12 and week 48 | — |
Countries
United Kingdom
Outcome results
None listed