Safety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral Experience
Recruiting
Phase 4
Interventional Study
HIV Infection
Metabolic Syndrome
Antiretroviral Treatment
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 124 (estimated)
- Sponsor
- Instituto Mexicano del Seguro Social · Government
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About This Trial
Background: The primary goal of antiretroviral therapy is to prevent HIV-associated morbidity and mortality. The effectiveness of first-line regimens is supported by a large number of clinical trials; current concerns focus on the long-term adverse effects of antiretrovirals, especially integrase strand transfer inhibitors, as they have been associated with significant weight gain, which may be as…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Men and women ≥18 years of age , diagnosed with HIV, and naive to antiretroviral treatment.
2. HIV-1 RNA quantified by RT-PCR ≥500 and less than 500,000 copies/mL.
3. No history of PrEP or PEP use.
4. Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 SC.
5. No current o…
Contacts