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Early versus late antiretroviral therapy in HIV positive adults

A comparative study on early versus late antiretroviral therapy in HIV positive adults

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/013784
Enrollment
250
Registered
2018-05-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- HIV positive patients Health Condition 2: B20- Human immunodeficiency virus [HIV]disease

Interventions

Intervention1: Early arm: The patient who report at the Antiretroviral center early in their course of disease having CD4 count between 350- 500 /mm3 will be recruited in early arm. Patients will be o

Sponsors

Department of Health Research Ministry of Health Family Welfare ICMR
Lead Sponsor
National AIDS Control Organisation
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: HIV infected patient in the age group >18 years belonging to male, female and transgender

Exclusion criteria

Exclusion criteria: 1.HIV infected patient in age group 2.Current pregnancy or breastfeeding (a negative serum or urine pregnancy test is required within 14 days before randomization for women of child-bearing potential) 3. Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness. 4.Cardiovascular event (myocardial infarction, angioplasty, coronary-artery bypass grafting, stroke) within 6 months before randomization 5. Non-AIDS-defining cancer, excluding basal and squamous cell skin cancer, within six months before randomization 6.Dialysis within six months before randomization

Design outcomes

Primary

MeasureTime frame
1.To compare the effects of early and delayed initiation of antiretroviral therapy on clinical outcomes of HIV positive adults 2.To assess the effect of early initiation of antiretroviral therapy on immunological status of HIV positive adults using CD4 count as surrogate marker. 3.To evaluate health related quality of life (HRQOL) of HIV/AIDS patients using world health organization quality of life- HIV brief instrument (WHOQOL-HIV BREF).Timepoint: 9 months—

Secondary

MeasureTime frame
1.Adverse drug reactions to antiretroviral drugs 2. Progression to AIDS 3. Survival rateTimepoint: 9 months—

Countries

India

Contacts

Public ContactDr Vikas Kumar

Government Medical College, Amritsar

drjatindersingh@gmail.com9876118935

Outcome results

None listed

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