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To study the effect of starting ART in newly infected HIV children,immediately versus delayed.

IMMEDIATE VS. POST- STABILIZATION START OF ANTIRETROVIRAL TREATMENT ( ART) IN HIV INFECTED CHILDREN: A RANDOMIZED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045358
Enrollment
40
Registered
2022-09-08
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: B20- Human immunodeficiency virus [HIV]disease

Interventions

Intervention1: Anti Retro viral Drug: 1.Abacavir +Lamivudine(FDC)(As per weight band) + Lopinavir for weight less then 20 kg or age below 6 years,for lifetime. 2.Abacavir +Lamivudine (FDC)(As per weig

Sponsors

Moti Lal Nehru Medical College Praygraj Uttar Pradesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All newly diagnosed HIV infected children from 2 years to 21 years.The diagnosis of HIV infection is as per NACO (National AIDS Controlling Organization) guidelines.

Exclusion criteria

Exclusion criteria: 1.Children needing Hospitalization. 2.Consent not given

Design outcomes

Primary

MeasureTime frame
1. Mortality or Admission during 3 months of enrollment in trial. 2. To asses the develpoment of IRIS(Inflammatory reconstitution syndrome) 3. To asses the drug toxicity Timepoint: 1. Mortality or Admission within 3 months of enrollment in trial. 2. To asses the develpoment of IRIS(Inflammatory reconstitution syndrome)

Secondary

MeasureTime frame
1.Change in WHO staging from enrollment to last follow -up during study. 2.Develpoment of oppurtunistic infections. 3.Change in anthropometric assesment from enrollment to last follow up during study. 4.Viral load suppression 5.CD4 count. Timepoint: 3 months

Countries

India

Contacts

Public ContactDr Sukesh sharma

Moti Lal Nehru Medical college

mukeshvirsingh@gmail.com9456630304

Outcome results

None listed

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