A study to check how Acyclovir (anti-viral medicine) effectively prevents acquiring chickenpox in patients varicella negative status, before getting exposed to chicken pox patients, who receiving treatment for blood cancer at Tata Memorial Hospital

Randomized control trial to test Pre-exposure prophylaxis (PreP) with Oral Acyclovir to prevent chickenpox in varicella-seronegative children with hematolymphoid malignancies receiving intensive chemotherapy in Tata Memorial Hospital.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/02/040455

Enrollment

382

Registered

2022-02-21

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Health Condition 1: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue Health Condition 2: B029- Zoster without complications

Interventions

Intervention1: Oral Acyclovir: Acyclovir or placebo will be dispensed as per the protocol assignment after randomization. Dose: 10mg/kg per dose rounded off to the nearest full or half tablet. Three t

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of hematolymphoid malignancy Receive 6 to 9 months of intensive chemotherapy at Tata Memorial hospital. Varicella IgG negative at baseline for randomization to acyclovir vs placebo arm. Varicella IgG positive children at baseline will be observed prospectively with 3 monthly varicella IgG titers.

Exclusion criteria

Exclusion criteria: Treatment abandonment prior to starting acyclovir. Treatment related mortality prior to starting acyclovir. Non-compliance on medications Refusal to extra blood draw for tracking IgG levels at diagnosis, 3 months and 6 months from diagnosis. Active suspected VZV infection

Design outcomes

Primary

Measure	Time frame
Measure the time to overt varicella infection from the time of enrolmentTimepoint: Screening, Diagnosis, 3,6,9 months, other assessments as per routine investigation requirements	—

Secondary

Measure	Time frame
Measure the time to Varicella related complications like pneumonitis in patients on PrEP compared to Placebo. Measure the number of days from onset of rash to complete resolution of rash in children who develop varicella in both the arms of the study. Measure the time delay in number of days between scheduled chemotherapy and actual date of chemotherapy administration from the time of varicella infection. Number of children who develop attenuated varicella in the children who received acyclovir PrEP Timepoint: Screening, Diagnosis, 3,6,9 months, other assessments as per routine investigation requirements	—

Measure

Time frame

Measure the time to Varicella related complications like pneumonitis in patients on PrEP compared to Placebo. Measure the number of days from onset of rash to complete resolution of rash in children who develop varicella in both the arms of the study. Measure the time delay in number of days between scheduled chemotherapy and actual date of chemotherapy administration from the time of varicella infection. Number of children who develop attenuated varicella in the children who received acyclovir PrEP Timepoint: Screening, Diagnosis, 3,6,9 months, other assessments as per routine investigation requirements

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Countries

India

Contacts

Public ContactChetan Dhamne

Tata Memorial Hospital

chetandhamne@gmail.com9136660746

Outcome results

None listed

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