HIV
Conditions
Brief summary
The primary endpoint will be a comparison of the percentage of participants in each treatment arm with undetectable plasma HIV RNA levels at week 48. Undetectable will be defined as plasma RNA levels of <50 copies/ml. Any patient with HIV RNA levels >50 copies/ml at analysis time points will have a repeat test. If the result from the repeat test is below 50 copies/ml the participant will be classified as a responder.
Detailed description
Absolute efficacy of study treatments: Proportion of patients treated on each arm with HIV viral load <50 copies/ml at weeks 24,72,96., Safety and tolerability: 1 Occurrence of adverse events (including laboratory results), severity of adverse events and occurrence of treatment discontinuations due to tolerability of treatments., Safety and tolerability- 2. Changes in CD4 count and CD4:CD8 ratio at screening, weeks 24, 48, 72 and 96, Safety and tolerability - 3. Occurrences and details of viral resistance in study participants, Safety and tolerability- 4. Scores from participant-recorded outcome measures at weeks 0, 24, 48, 72 and 96: • EuroQoL Questionnaire • Patient Treatment Satisfaction Questionnaire • Pittsburgh Sleep Questionnaire
Interventions
Sponsors
Chelsea And Westminster Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be a comparison of the percentage of participants in each treatment arm with undetectable plasma HIV RNA levels at week 48. Undetectable will be defined as plasma RNA levels of <50 copies/ml. Any patient with HIV RNA levels >50 copies/ml at analysis time points will have a repeat test. If the result from the repeat test is below 50 copies/ml the participant will be classified as a responder. | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute efficacy of study treatments: Proportion of patients treated on each arm with HIV viral load <50 copies/ml at weeks 24,72,96., Safety and tolerability: 1 Occurrence of adverse events (including laboratory results), severity of adverse events and occurrence of treatment discontinuations due to tolerability of treatments., Safety and tolerability- 2. Changes in CD4 count and CD4:CD8 ratio at screening, weeks 24, 48, 72 and 96, Safety and tolerability - 3. Occurrences and details of viral resistance in study participants, Safety and tolerability- 4. Scores from participant-recorded outcome measures at weeks 0, 24, 48, 72 and 96: • EuroQoL Questionnaire • Patient Treatment Satisfaction Questionnaire • Pittsburgh Sleep Questionnaire | — |
Countries
Italy
Outcome results
None listed