Long Acting Cabotegravir Plus Rilpivirine in People Living With HIV-1 Aged ≥ 60 Years for 24 Months. (LOVER60)
People Living with HIV-1 (PLHIV) are an important group of patients attending their specialist's and continue growing thanks to efficacy antiretroviral treatment (ART), allowing them to stabilize the HIV-infection and to live a normal life despite the infection. The present study is encouraged to demonstrate that efficacy and security of CAB LA + RPV LA treatment's on this population remains the same compared to younger population of patients. This study also registers some metabolic and hepatic parameters to observe a hypothetical improvement on these parameters, as the population may suffer more comorbidities than younger population and therefore tolerability and convenience gains a huge importance on them. Psychosocial aspects are also very important in these patients as these patients may suffer social stigma, and therefore suffering certain psychological disorders.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Alicante
-
Elche、Alicante、スペイン、03203
- Hospital General Universitario de Elche
-
Villajoyosa、Alicante、スペイン、03570
- Hospital Marina Baixa
-
-
Murcia
-
Cartagena、Murcia、スペイン、30202
- Hospital General Universitario Santa Lucía
-
Lorca、Murcia、スペイン、30813
- Hospital Universitario Rafael Mendéz de Lorca
-
Murcia、Murcia、スペイン、30008
- Hospital General Universitario Morales Meseguer
-
Murcia、Murcia、スペイン、30003
- Hospital General Universitario Reina Sofia
-
Murcia、Murcia、スペイン、30100
- Hospital Clinico Universitario Virgen de la Arrixaca Murcia
-
Pozo-Aledo、Murcia、スペイン、30739
- Hospital General Universitario Los Arcos del Mar Menor
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Be able to understand and comply with protocol requirements, instructions, and restrictions.
- Understand the long-term commitment to the study and be likely to complete the study as planned.
- Be considered appropriate candidates for participation in an investigative clinical trial with oral and intramuscularly injectable medications (e.g., no active substance use disorder, acute major organ disease, or planned long-term work assignments out of the country, etc.).
- Must be on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class.
- Plasma HIV-1 RNA <50 copies/mL at screening.
- A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum hCG test at screen and a negative urine hCG test at randomization) and not lactating
Exclusion Criteria:
- Plasma HIV-1 RNA measurement ≥50 copies/mL within 6 months prior to screening. Blips are allowed (increased viral load ≥50 copies/mL but <200 copies/mL preceded and followed by a viral load less than 50 copies/mL)
- Any drug holiday during the window between initiating first HIV ART and 6 months prior to screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns.
- Any switch to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to NNRTI or INSTI (defined as a confirmed plasma HIV-1 RNA measurement ≥200 copies/mL after initial suppression to <50 copies/mL while on first line HIV therapy regimen)
- Subjects who are currently participating in or anticipate being selected for any other interventional study. Observational studies and intervention studies that do not include treatments are allowed unless they interfere with scheduled visits.
- Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternative medication
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：CAB LA + RPV LA
the proportion of participants ≥60 years on stable oral ART that switch to CAB LA + RPV LA with plasma HIV-1 RNA ≥50 copies/mL at month 12 in the intention-to- treat exposed (ITT-E) population |
Cabotegravir (CAB) LA 600mg and Rilpivirine (RPV) LA 900mg will be administered intramuscularly every 2 months after an induction phase with a single administration in months 1 and 2. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Numer of patients on stable oral ART that switch to CAB LA + RPV LA with plasma HIV-1 RNA ≥50 copies/mL
時間枠：Up to 12 Months
|
Proportion of participants ≥60 years on stable oral ART that switch to CAB LA + RPV LA with plasma HIV-1 RNA ≥50 copies/mL at month 12 in the intention-to-treat exposed (ITT-E) population, per the FDA Snapshot algorithm. |
Up to 12 Months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Levels of HIV-1 RNA Copies
時間枠：6, 12 and 24 Months
|
To evaluate other estimations of virological control and number of episodes of plasma HIV-1 RNA ≥50 copies/mL that do not meet the criteria for confirmed virological failure |
6, 12 and 24 Months
|
|
Levels of HIV-1 RNA Copies (plasma HIV-1 RNA ≥200 copies/mL)
時間枠：12 and 24 Months
|
To determine the proportion of participants experiencing confirmed virologic failure |
12 and 24 Months
|
|
Number of Participants with experienced CVF (confirmed virologic failure)
時間枠：6, 12 and 24 Months
|
To asses treatment emergent genotypic and phenotypic resistance in participants experiencing CVF. Levels of hiv-1 RNA copies |
6, 12 and 24 Months
|
|
To evaluate the immune effects of switching to CAB LA + RPV LA
時間枠：6, 12 and 24 Months
|
Plasma levels of (CD4 and CD4/CD8), |
6, 12 and 24 Months
|
|
Number of SAES/SUSAR in patients treated with CAB LA + RPV LA
時間枠：6, 12 and 24 Months
|
evaluation of parameters ensuring efficacy and security of patients, Number of SAES/SUSAR |
6, 12 and 24 Months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
CD4/CD8 ratio
時間枠：6, 12 and 24 Months
|
To assess the change in CD4/CD8 ratio |
6, 12 and 24 Months
|
|
HIV Status
時間枠：6, 12 and 24 Months
|
Questionnaire status version (HIVTSQs), |
6, 12 and 24 Months
|
|
HIV Treatment Satisfaction
時間枠：6, 12 and 24 Months
|
Perception of injection questionnaire (PIN) |
6, 12 and 24 Months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IMIB-LOVER60-2022-03
- 2022-502882-53-00 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。