| Study ID: |
ACTG5257 |
| Description: |
Comparison of three different initial treatments. |
| Medications: |
Atazanavir/Ritonavir vs. Darunavir/Ritonavir vs. Raltegravir. All with Truvada. |
| Requirements: |
HIV RNA > 1000 |
| Duration: |
96 weeks (about 2 years) |
| Compensation: |
All drugs except Ritonavir provided. |
| Study ID: |
CCTG589 |
| Description: |
Comparison of two different regimens |
| Medications: |
Raltegravir + Kaletra vs. Atripla |
| Requirements: |
HIV RNA > 5000, CD4>50 |
| Duration: |
48 weeks – about one year |
| Compensation: |
Kaletra and Raltegravir provided. $20 per visit, once enrolled. |
| 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: |
A5256 |
| Description: |
Effect of adding Maraviroc to a suppressive ARV regimen with suboptimal CD4 count recovery. |
| Medications: |
Maraviroc |
| Requirements: |
Currently on antiviral therapy for at least two years with no changes for the past 24 weeks. CD4< 250 mL. Undetectable HIV RNA. |
| Duration: |
48 weeks (about 1 year). |
| Compensation: |
Maraviroc provided |
| 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. |
|
|
|
| HIV
Complications and Coinfections Studies |
| Study ID: |
ACTG 5259 |
| Description: |
Comparison of regimens to prevent Tuberculosis among HIV-infected high-risk PPD TB skin-test reactors. |
| Medications: |
Weekly Rifapentine for three months vs. Daily Isoniazid for none months. |
| Requirements: |
HIV positive, but HIV treatment naïve. TB treatment naïve. PPD skin test reactors at high risk for developing TB. No active TB. |
| Duration: |
33 months (about 2.5 years) |
| Compensation: |
TB medications provided |
|
| |
|
|
| 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: |
ACTG 5247 |
| Description: |
Zostavax (live herpes zoster vaccine) in HIV infected adults |
| Medications: |
Zostavax vs. placebo (3:1) |
| Requirements: |
On stable Antiviral Therapy. CD4>350 mL. Undetectable HIV RNA. CD4 nadir (lowest ever) NOT less than 100. |
| Duration: |
12 – 14 weeks |
| Compensation: |
Zostavax provided |
| 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, Either HIV RNA > 10,000 OR CD4 < 350. |
| 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. |
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| |
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