Analysis of Telmisartan Administered With Antiretroviral Therapy (ART) in Patients With Acute HIV Infection (SEARCH018)
Acute HIV Infection, HIV Infections
About this trial
This is an interventional other trial for Acute HIV Infection focused on measuring Acute HIV infection, Central nervous system, Antiretroviral therapy, Telmisartan, Cerebrospinal fluid
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old
- Have protocol-defined acute HIV-1 infection
- Be part of the SEARCH 010/RV 254 study in Bangkok, Thailand
- Ability and willingness to start ART immediately after diagnosis
- Availability for follow-up for the duration of the planned study
- Systolic blood pressure ≥ 110 mmHg
- Agree to undergo lumbar puncture at weeks 0, 48 and 72
- Ability and willingness to provide informed consent. Subjects must understand the study and sign the consent form. Persons who cannot read will have the consent form read to them by a member of the study staff and may then give informed consent by using making a thumb print.
Exclusion Criteria:
- Pregnancy (current or within the last 6 months) or breastfeeding
- Uncontrolled hypertension
- Use of thiazolidinediones or other angiotensin receptor blockers class [losartan, irbesartan, olmesartan, valsartan, candesartan (washout permitted)]
- Screening laboratory values: absolute neutrophil count < 750 cells/mm3, hemoglobin <10 gm/dL creatinine clearance <30 mL/min (estimated by the Cockcroft-Gault equation using ideal body weight)
- Known renal artery stenosis
- Known cirrhosis or severe liver disease
- Unstable coronary artery disease/angina or decompensated congestive heart failure
- Any history of intolerance to any angiotensin receptor blocker
- Need for ongoing potassium supplementation
- Any contraindication to lumbar puncture such as history of bleeding diathesis or cerebral mass lesion
Sites / Locations
- Chulalongkorn University Hospital
- Thai Red Cross AIDS Research Centre
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Antiretroviral Therapy (ART) only
ART + Telmisartan
Acute HIV-infected subjects (n=7) will be randomly assigned to a group that will receive antiretroviral therapy (the current standard of care for HIV patients) for 72 weeks.
Acute HIV-infected subjects (n=14) will be randomly assigned to a group that will receive treatment with telmisartan in addition to ART. Subjects will receive 40mg telmisartan daily for 4 weeks, followed by 80mg telmisartan daily for 44 weeks, to be taken in conjunction with ART. Subjects unable to tolerate 80mg of telmisartan will be able to de-escalate to 40mg daily. After telmisartan is stopped, subjects will continue to take ART for an additional 24 weeks (total 72 weeks).