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Acute HIV Infection clinical trials

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NCT ID: NCT03711253 Not yet recruiting - Acute HIV Infection Clinical Trials

Empiric Treatment for Acute HIV in the ED

EMTreatED
Start date: November 2018
Phase: Phase 4
Study type: Interventional

An acceptance and feasibility study for immediate ART initiation and storage of laboratory specimens for individuals with suspected acute HIV infection who are diagnosed in one of the 7 participating emergency rooms

NCT ID: NCT03579381 Recruiting - HIV-1-infection Clinical Trials

Specimen Repository for HIV Immunopathogenesis

Start date: July 31, 2017
Phase:
Study type: Observational

Specimen Repository for HIV Immunopathogenesis Studies

NCT ID: NCT02750059 Active, not recruiting - Acute HIV Infection Clinical Trials

Using Telmisartan With ART During Acute HIV Infection to Reduce the CNS Reservoirs of HIV and Lymph Node Fibrosis

Start date: January 2015
Phase: Phase 2
Study type: Interventional

Primary objective: To compare telmisartan therapy + antiretroviral therapy (ART) versus ART alone during acute Human Immunodeficiency Virus (HIV)a infection in reducing systemic immune activation and trafficking of activated and HIV-infected cells to the central nervous system (CNS), and limiting establishment and persistence of the CNS reservoir of HIV. At 48 weeks (during the telmisartan therapy) and 72 weeks (~6 months after cessation of telmisartan augmentation), the investigator expect subjects in the telmisartan group will have reduced levels of blood and CSF immune activation markers, reduced brain inflammation, lower CSF HIV ribonecleic acid (RNA) and improved neuropsychological testing performance. Secondary objective: In subjects who are willing to undergo the optional inguinal lymph node biopsy, the study will determine whether subjects receiving telmisartan plus ART for 48 weeks develop less lymphoid tissue fibrosis than subjects receiving ART alone for 48 weeks. Subject population: Male and female subjects age ≥ 18 years old with acute HIV infection who are identified and enrolled in SEARCH 010/RV254 protocol will be asked to co-enroll in this study. Number of subjects: 21 Duration of follow-up: 72 weeks Study design: 21 acutely HIV-infected subjects will be randomized 2:1 to treatment with telmisartan + ART (n=14) vs. ART alone (n=7) for the first 48 weeks followed by ART alone in both arms to week 72. Blood and CSF, magnetic resonance imaging (MRI), and neuropsychological testing and exam will be collected at baseline, week 48 and week 72. Inguinal lymph node biopsy is an optional procedure that will be offered at baseline and week 48.

NCT ID: NCT02614950 Completed - Acute HIV Infection Clinical Trials

Viral Suppression After Analytic Treatment Interruption in Thai Patients Who Initiated Highly Active Antiretroviral Therapy During Acute HIV Infection

Start date: February 2016
Phase: N/A
Study type: Interventional

This is a Phase 2, two-step, open-label study of the outcome of analytic treatment interruption (ATI) on patients who started antiretroviral therapy (ART) during Fiebig Stage I of acute HIV infection (AHI), defined as detectable HIV-RNA without detectable p24 antigen or HIV IgM. The primary endpoint will be rate of sustained viral suppression, defined as HIV-1 RNA < 50 cps/ml at 24 weeks after treatment interruption. During ATI subjects will be monitored closely for safety and will have ART re-initiated if they meet predefined clinical, virological, or immunological criteria. In step I, there will be 8 subjects who undergo ATI. An interim analysis for safety will be conducted after 12 weeks. If none of the subjects maintain viral suppression at 12 weeks then no further subjects will be enrolled into the study. If at least 1 out of 8 subjects maintains viral suppression at 12 weeks then an additional 7 subjects will be enrolled in step 2. At ATI all antiretroviral drugs will be discontinued. Subjects will be monitored with clinical exam, immunological (CD4), and virological (HIV-RNA) testing at baseline and then on a fixed schedule for 24 weeks. ART will be re-initiated immediately if subjects meet any pre-defined clinical, immunological or virological safety endpoints during the monitoring period.

NCT ID: NCT02475915 Completed - Acute HIV Infection Clinical Trials

Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection

Start date: January 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a two-arm prospective 1:1 randomised controlled trial comparing the proportion of patients between: Group 1: vorinostat/hydroxychloroquine/maraviroc (VHM) co-administered with anti-retroviral therapy (ART) Group 2: ART only who are able to maintain HIV RNA < 50 copies/ml following treatment interruption. Subjects will be recruited from RV254/SEARCH 010, an acute HIV infection cohort conducted by the Thai Red Cross AIDS Research Centre in Bangkok, Thailand. The study will run for a minimum of 34 weeks from screening.

NCT ID: NCT02470351 Completed - Acute HIV Infection Clinical Trials

Assessment of the HIV CNS Reservoir, Neurological and Neuro-cognitive Effects, and Source of Rebound HIV in CNS

Start date: January 2015
Phase: N/A
Study type: Observational

This study aims to describe in depth the CNS, CNS HIV reservoir and CNS viral rebound in consenting SEARCH 019 subjects prior to, during and after the SEARCH 019 study intervention (VHM + ART or ART only), at 1) baseline, 2) end of study intervention and start of ART interruption, 3) viral rebound (if occurring) or mid-way during observed ART interruption, and 4) at the end of ART interruption. Study SEARCH 026 itself does not employ any therapeutic interventions. However, consenting subjects will participate in lumbar puncture, non-contrast MRI + MRS, and neuropsychological testing at at least three and at most four time points. Any of the 15 subjects to be enrolled in SEARCH 019 may consent to study SEARCH 026 participation and hence a maximum of 15 subjects may enroll. As this is a sub-study, data will be shared from study SEARCH 019 and no interventions (venipunctures) will be repeated unnecessarily.

NCT ID: NCT02467439 Recruiting - Clinical trials for Sexually Transmitted Infections

Acute Partner and Social Contact Referral: iKnow

Start date: June 2015
Phase: N/A
Study type: Interventional

The primary purpose of this research is to assess the benefit of an "unaware intervention package" for identifying high risk persons who are unaware of their HIV infection status. This intervention package includes screening for acute HIV infection, contract sexual partner referral, and peer referral.

NCT ID: NCT02384395 Recruiting - HIV Clinical Trials

Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection

PHI 05
Start date: September 2015
Phase: N/A
Study type: Interventional

This is a multicenter, single arm, 96-week open-label study of the safety and virologic efficacy of fixed dose combination Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC FDC) initiated during acute HIV infection (AHI).

NCT ID: NCT02231281 Active, not recruiting - Acute HIV Infection Clinical Trials

Early cART and cART in Combination With Autologous HIV-1 Specific Cytotoxic T Lymphocyte (CTL) Infusion in The Treatment of Acute HIV-1 Infected Adults

Start date: August 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the ability of the early initiation of cART or cART in combination with autologous HIV-1 specific cytotoxic T lymphocyte (CTL) infusion to achieve a post-treatment control among treatment-naïve acute HIV-infected adults.

NCT ID: NCT02170246 Recruiting - HIV Infections Clinical Trials

Analysis of Telmisartan Administered With Antiretroviral Therapy (ART) in Patients With Acute HIV Infection

SEARCH018
Start date: August 2014
Phase: Phase 1
Study type: Interventional

This research project will study whether the drug telmisartan administered in conjunction with antiretroviral therapy (ART) will help reduce nervous system infection with HIV. The investigators are studying the effect of this treatment in people who have contracted HIV infection within the past three weeks, and thus have a form of HIV called acute HIV infection. The investigators will measure biological markers of immune activation in the blood and cerebrospinal fluid to see if telmisartan may reduce the spread of HIV reservoirs in affected patients.