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Early versus late antiretroviral therapy in HIV positive adults

Not Applicable
Conditions
Health Condition 1: null- HIV positive patientsHealth Condition 2: B20- Human immunodeficiency virus [HIV]disease
Registration Number
CTRI/2018/05/013784
Lead Sponsor
Department of Health Research Ministry of Health Family Welfare ICMR
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

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

Exclusion Criteria

1.HIV infected patient in age group < 18 years.

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.To compare the effects of early and delayed initiation of antiretroviral therapy on clinical outcomes of HIV positive adults <br/ ><br>2.To assess the effect of early initiation of antiretroviral therapy on immunological status of HIV positive adults using CD4 count as surrogate marker. <br/ ><br>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 Outcome Measures
NameTimeMethod
1.Adverse drug reactions to antiretroviral drugs <br/ ><br>2. Progression to AIDS <br/ ><br>3. Survival rateTimepoint: 9 months
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