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Don't Miss the Diagnosis
Acute HIV-1 infection is an often-misdiagnosed cause of an acute flu-like or mono-like illness. Recognition has important implications in terms of treatment and prevention of transmission.
Referral for Acute HIV-infection testing should be considered in patients with a recent history of unprotected sexual activity, needle sharing, or other potential exposure to HIV
And
Have the presence of one or more of the following signs and symptoms:
- Fever
- Rash
- Lymphadenopathy
- Oral, Genital, or Rectal Ulcers
- Exudative Pharyngitis
- Aseptic Meningitis Headache, Photophobia, Stiff Neck)
- Myalgia/Arthralgia
- Fatigue
- Weight Loss
- Night Sweats
- Anorexia
For Healthcare Providers
If you have a patient with a history of possible exposure to HIV
And
Symptoms consistent with early HIV infection, our project offers HIV counseling and screening through a research protocol.
Diagnosis of early HIV infection is made on the basis of the standard ELISA/Western Blot and HIV RNA PCR (viral load), which is currently not an approved test for diagnosis of acute HIV outside of a research study.
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Treatment Naïve
Studies in this section are for people who have never taken HIV medications before.
| Study Number | A5257 |
| Study Name | A Phase II Comparative Study of Three Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) - Sparing Antiretroviral Regimens for Treatment-Naive HIV-1-Infected Volunteers. |
| Description | HIV-1-infected, ARV-drug naive men and women >/=18 years of age with any HIV-1 RNA level and any CD4+ T-cell count who are candidates for treatment with 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus raltegravir (RAL), atazanavir/irtonavir (ATV/r) or darunavir/ritonavir (DRV/r) and have no evidence of any major NRTI or protease inhibitor (PI) resistance-associated mutation. |
| Who Is Eligible | Men and Women >/=18 years old No major NRTI or PI resistance-associated mutations |
| For More Information | Call (212) 305-7897 or e-mail HIV_Studies@columbia.edu |
| Study Number | MRK055 |
| Study Name | A phase III open-label single arm study to evaluate the safety, tolerability, and efficacy of MK-0518/Raltegravir in a diverse cohort or HIV-Infected patients. |
| Description | This is a study of long term safety and tolerability f/u of minority and/or women volunteers starting a Raltegravir containing regimen. |
| Who Is Eligible | Men and women age 21 or older Starting a Raltegravir containing regimen |
| For More Information | Call (212) 305-7897 or e-mail HIV_Studies@columbia.edu |
| Study Number | Latent TB A5259 |
| Study Name | A study of the effectiveness and tolerability of weekly Rifapentine/lsoniazid for three months versus daily isoniazid for nine months for the treatment of latent Tuberculosis infection. |
| Description | The primary objective of this open-label phase III clinical trial is to compare the effectiveness of a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) to the effectiveness of a nine-month (270-dose) regimen of daily isoniazid (9INH). This trial will be conducted among high-risk tuberculin skin-test reactors, including children and HIV-infected persons, who require treatment of latent infection (TLI) to prevent tuberculosis (TB). The 3RPT/INH regimen will be given under direct observation and the 9INH regimen will be primarily self-administered. |
| Who Is Eligible | Men and non-pregnant non-breastfeeding women age 21 years old and above Not on ARVs and not planning to start ARvs for a few months |
| For More Information | Call (212) 305-7897 or e-mail HIV_Studies@columbia.edu |
| Study Number | A5217 |
| Study Name | The SETPOINT Study – A Randomized Study of the Effect of Immediate Treatment with Potent Antiretroviral Therapy versus Observation with Treatment as Indicated in Newly Infected HIV-1-infected Subjects: Does Early Therapy Alter the Virologic Setpoint? |
| Description | The goal of this study is to determine whether immediate, short-term therapy (9 months of anti-HIV medications) for people with recently acquired HIV infection, is beneficial as opposed to delaying therapy until standard criteria for treatment are met.
Volunteers who have been infected with HIV within approximately 6 months will be randomized (assigned by chance, like flipping a coin) into one of two groups:
Group 1 Truvada® and Kaletra® for 36 weeks
Group 2 No treatment unless HIV progression occurs The study will determine whether the viral load 72 weeks into the study is lower in people who received treatment initially. Any volunteer who meets standard criteria for treatment will be offered HIV treatment. |
| Who Is Eligible | Persons at least 18 years of age who were infected with HIV within approximately 6 months, with T cells (CD4 count) >350 cells/mm3 and plasma HIV-1 RNA >500 copies/mL |
| For More Information | Call (212) 305-7897 or e-mail |





