Open Studies

Antiretroviral studies for treatment-naïve adults

Study ID: ACTG 5248
Description: Viral decay rates in treatment naïve patients initiating Raltegravir + Truvada (TDF/FTC).
Medications: Raltegravir + Truvada
Requirements: Treatment naïve. HIV RNA > 10,000 and < 300,000
Duration: 72 weeks
Compensation: Raltegravir provided.

Study ID: TMC278-TiDP6-C209
Description: TMC278 vs. Efarivenz (Sustiva) Comparison of initial regimens
Medications: TMC278 + Truvada vs. Sustiva + Truvada
Requirements: Treatment naïve. HIV RNA > 5000.
Duration: About 2 years
Compensation: $30 per visit, once enrolled. All study drugs provided.
Antiretroviral studies for treatment-experienced adults
Study ID: Schering-Plough - P05241
Description: Effect of Vicriviroc (CCR5 chemokine receptor antagonist) on HIV RNA levels in cerebrospinal fluid.
Medications: Vicriviroc added to failing regiment for two weeks. Then switch to optimized background regimen.
Requirements: CD4 > 150. HIV RNA > 1000 copies mL. HIV isolate must be soley CCR5 tropic. Currently receiving a boosted protease inhibitor regimen.
Duration: $20 for non-LP visits. $75 for LP visits.
Compensation: Vicriviroc provided.

Study ID: ACTG 5241
Description: Optimized treatment to include or omit NRTIs for highly treatment experienced patients.
Medications: Selected regimens chosen from the following treaments: enfuvirtide (Fuseon), MK-0515, darunavir/RTV, etravirine, tipranavir/RTV, and two NRTIs or not two NRTIs.
Requirements: Triple-class ARV experience or resistance. Currently taking a protease inhibitor. No experience with any integrase inhibitor, etravirine, or TMC278. HIV RNA > 1000.
Duration: 48 weeks (about 1 year).
Compensation: Study medications provided.

Study ID: A5227
Description: (“Nearly naïve” study for women) – The effects of past ARV therapy used for prevention of Mother-Child transmission (pMTCT) on efficacy of new treatment regimen.
Medications: Sustiva + Truvada is provided, but any standard regimen is acceptable.
Requirements: Women > 16 years old. Antiretroviral therapy for a maximum of 40 weeks for pMTCT. No ARV therapy for the previous 6 months. HIV RNA > 500. Ready to begin ARV therapy.
Duration: 48 weeks (about 1 year)
Compensation: Sustiva and Truvada provided if used.

Study ID: Koronis 1461-201
Description: Proof of concept study for “covert nucleoside”. All receive the same dose.
Medications: KP 1461 twice daily for 124 days. KP 1461 works through a process that causes viral decay acceleration.
Requirements: Currently off HIV medications at least 16 weeks. Triple class resistance. CD4 > 250.
Duration: About 4 months
Compensation: Drug provided. $50 per visit .(up to $750).
HIV Complications Studies
 
 
Study ID: ACTG 5235
Description: Minocycline for Cognitive Impairment
Medications: Minocycline vs. placebo; all offered drug after 24 weeks.
Requirements: On stable ARV regimen. Progressive neurocognitive impairment.
Duration: 48 weeks (about 1 year)
Compensation: Minocycline provided
 
 
 
Acute / early-phase infection studies for adults
     
Study ID: AEH 027
Description: Observational study of factors related to the transmission of HIV infection.
Medications: Non-applicable
Requirements: Partners of those taking the Early Test (nucleic acid testing).
Duration:
Compensation:

Study ID: AEH 020
Description: Observational study of factors related to the acquisition of HIV infection.
Medications: Non-applicable
Requirements: Acute and early (< 3 months) HIV infection. Treatment naïve.
Duration:
Compensation:

Study ID: AEH 001
Description: Observation of the development of HIV disease
Medications: Not part of the study
Requirements: Adults in the acute / early phase of HIV infection (less than 12 months)
Duration: Ongoing study (no end date)
Compensation: Free examinations and monitoring of viral activity. Compensation provided after enrollment.
     
     
     
 Additional studies for adults
Study ID: ACTG5240
Description: The HPV recombinant vaccine (Gardisal) in HIV+ women
Medications: Gardisal vaccine
Requirements: HIV+ females, age 18 – 45. No history of cervical cancer, no genital warts within 6 months, o prior HPV vaccinations
Duration: 72 weeks
Compensation: $20 per visit plus compensation for certain tests. Gardisal vaccine provided

Study ID: ACTG5239
Description: Pioglitazone for HCV infection w/ insulin resistance and non-response to HCV therapy. Open label, pilot study.
Medications: Pioglitazone, then add Peg-1 IFN/RBV.
Requirements: HIV/HCV coinfection (HCV genotype 1). Insulin resistance. Nonresponse to Peg IFN/RBV. CD4 > 200. Must be on stable or no antiretroviral therapy for 12 weeks.
Duration: About 2 years
Compensation: All study drugs provided.

Study ID: ACTG 5232
Description: Determining immune defects and vaccine responsiveness in people with either HIV, HCV, or both.
Medications: HIV medications: All participants will be immunized with antibodies to both tetanus toxoid and hepatitis A and B to evaluate immune response.
Requirements: I) HIV+ (HCV negative): a CD4>300. Treatment naïve with no need for starting ARV Tx. OR II) HCV+ (HIV negative). HCV treatment naïve. No cirrhosis. OR III) HIV/HCV coinfected as described in I and II.
Duration: 24 weeks (about 6 months)
Compensation: Vaccine provided.
     
Study ID: ACTG 5221
Description: Immediate vs. deferred antiretroviral therapy in patients co-infected with TB
Medications: HIV medications: Efavirenz, tenofovir, FTC (substitutions allowed). Initiate HIV treatment within 2 weeks of initiating TB treatment vs. initiate HIV treatment within 8-12 weeks of initiating TB treatment.
Requirements: Confirmed or probable TB. Rifampin initiated within 14 days of study entry. CD4 < 200. HIV treatment naïve.
Duration: 48 weeks (about 1 year)
Compensation: Some medications provided.

Study ID: GS-US-197-0101
Description: Ointment for treatment of external genital and perianal warts
Medications: Ointment vs. placebo
Requirements: Male or female. HIV positive or negative. Presence of at least two external anogenital warts. If HIV positive, HIV RNA < 400 and CD4 > 400 and currently on HAART.
Compensation: Ointment provided.