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Timing of antiretroviral therapy for HIV-infected patients with cytomegalovirus retinitis: study protocol of a multi-center prospective randomized controlled trial

A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031202
Enrollment
Unknown
Registered
2020-03-24
Start date
2019-02-11
Completion date
Unknown
Last updated
2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-infected patients with cytomegalovirus retinitis

Interventions

Early ART group:initiation of ART within 2 weeks after starting CMVR treatment
Delayed ART group:initiation of ART more than 2 weeks after starting CMVR treatment

Sponsors

Chongqing Public Health Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: The study will include HIV-infected patients who are ART-naive, 18 years or older, and have been diagnosed with CMVR. Prospective participants must be willing to complete and sign informed consent documentation. All of the above criteria will have to be met before inclusion in the study.

Exclusion criteria

Exclusion criteria: 1. they are intolerant or have allergies to any therapeutic drugs; 2. they have laboratory study anomalies viz. hemoglobin (Hb) 2 UNL, serum creatinine (Scr) >1.5 UNL, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (ALP) >5 UNL, total bilirubin (TB) >2 UNL, serum creatine phosphokinase (CK) >2 UNL; 3. they have other serious disease that may adversely affect the evaluation of the efficacy of therapeutic drugs and prognosis of patients; 4. they are women who are pregnant or breast-feeding; 5. they have mental illness, are intravenous recreational drug users, or are non-Chinese nationals.

Design outcomes

Primary

MeasureTime frame
The incidence of visual loss;—

Secondary

MeasureTime frame
Comparison of the difference in CD4+ T-cell counts between the two study groups from baseline to week 48;; Comparison of virological suppression (HIV RNA <50 copies/mL) between the two study groups at different follow-up points from baseline to week 48;;Comparison of the difference in the incidence of IRU between the two study groups during the study period;;Comparison of the occurrence of adverse events between the two study groups during the study period;;The incidence of other opportunistic infections (OIs) in the two study groups during the 48 weeks of follow-up;The incidence of retinitis progression and retinal detachment between the two study groups during the study period;; The overall mortality in the two study groups at week 48;—

Countries

China

Contacts

Public ContactYaokai Chen

Chongqing Public Health Medical Center

yaokaichen@hotmail.com13838352995

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026