How to Participate
If you are interested in participating in a study, contact the AIDS Clinical Trial Group (ACTG) for more information about the study and to discuss your eligibility.
These studies are conducted by the AIDS Clinical Trials Group (ACTG). If you are interested in participating in a study, call ACTG at (617) 726-3819 to speak with a study nurse. Always talk with your primary care provider about any study you are interested in to make sure it is right for you.
All Studies
ACTG A5315 (Romidepsin RMD)
This is a phase I/II safety, dose-escalation, and preliminary efficacy study of romidepsin (RMD), a histone deacetylase inhibitor, in HIV-infected subjects with suppressed viremia on a PI-sparing regimen. Subjects will complete the study in 4 to 8 weeks. Participants will be admitted to the inpatient Clinical Research Unit and will be compensated for their time.
Purpose
The overall goal of this exploratory study is to identify single doses of RMD that are safe and well-tolerated in HIV-infected subjects with HIV-1 RNA levels < 50 copies/mL on a stable ART regimen and to assess the induction of HIV-1 expression in HIV-infected subjects with suppressed viremia by measuring plasma viremia using a single copy HIV-1 RNA assay prior to RMD dosing and at other defined time points after initiation of RMD dosing.
Requirements
- Documented HIV infection and ≥ 18 years of age
- CD4+counts > 300 cells/mm3, HIV-1 RNA levels < 50 copies/mL and no blips > 50 copies/mL for past
24 months, HIV-1 RNA level > 0.4 copies/mL by single-copy assay (SCA) - Negative HCV Antibody and HBsAg results within 90 to 50 days prior to study entry
- No history of or current malignancy requiring cytotoxic therapy
- No history of seizure disorders
ACTG A5325 (Isotretinoin)
This study is an open-label, randomized, two arm pilot trial of isotretinoin therapy to compare the changes in expression levels of CD38/HLA-DR on CD8+ T cells after 16 weeks of treatment followed by 12 weeks of observation on ART alone. Arm A (Treatment) will receive isotretinoin at approximately 0.5mg/kg po once daily for 4 weeks, then increased to approximately 1.0 mg/kg po once daily for 12 weeks or Arm B (Control) No treatment. This is a 28-week study.
Purpose
The main purpose of the study is to evaluate the effect of isotretinoin on changes in expression levels of CD38/HLA-DR on CD8+ T cells, the safety and tolerability of isotretinoin in HIV-infected participants on antiretroviral therapy (ART).
Requirements
- Documented HIV infection, men and post-menopausal females≥ 18 years of age
- HIV-1 RNA < 75 copies/mL
- No active hepatitis B or C
- No history of diabetes
- No severe psychiatric disorders
- Willingness to adhere to the IPledge program (on-line program for dispensing isotretinoin and preventing pregnancy)
ACTG A5330s (Gut Mucosa/Colonoscopies/Biopsies)
This is a sub-study of A5325. It will evaluate the change in CD4+ Tcell percentage in the lining of the intestines. Samples will be collected via colonoscopy with biopsies immediately prior to the start of A5325 study treatment and followed its completion at week 16. Nationally, targeted enrollment is 30 subjects.
Purpose
The main purpose of the study is to evaluate change in CD4+ T cell reconstitution in the lining of the intestines after treatment with isotretinoin.
Requirements
- Must be enrolled in A5325
- Commitment to two colonoscopies with biopsies within a 4-month period and who have no contraindications for colonoscopy
ACTG A5314 (Low Dose Methotrexate/FMD)
This is a phase II, randomized double blind, placebo-controlled trial to evaluate the safety and efficacy of Low Dose Methotrexate (LDMTX) on endothelial function, assessed by flow-mediated vasodilatation (FMD) of the brachial artery. Key inflammatory markers of CVD risk and T-Cell activation in the blood, and size of the HIV reservoir will be measured during the study. Subjects will be randomized to receive LDMTX or matching placebo. Subjects will take 5mg x 1 wk, 10mg x 11 wks and 15mg x 12 wks totally 24 weeks of drug/placebo followed by observation for an additional 12 weeks. This is a 24-week study.
Purpose
This study will assess the safety and effects of LDMTX on endothelial function (assessed by flow-mediated vasodilation of the brachial artery), key inflammatory markers of cardiovascular disease risk (high-sensitivity C-reactive protein), interleukin-6, soluble CD163 (sCD163), D-dimer, T-cell and monocyte activation in the blood, and size of the HIV reservoir.
Requirements
- HIV+ men and women (not of childbearing potential) ≥ 40 yrs of age
- Continuous ART for ≥24 weeks prior to study entry
- CD4+ T-cell count ≥400 cells/mm3 obtained within 60 days prior to study entry
- HIV-1 RNA level <20 copies/mL for at least 24 weeks prior to study entry
- Documented CVD or increased risk for CVD
- Any one of the following CVD risk factors: 1) CAD 2) Cerebrovascular Disease 3) Peripheral Arterial Disease 4) Controlled Diabetes 5) Current smoking: subject report of smoking at least half a pack of cigarettes a day, on average, in the past month 6) Hypertension 7) Dyslipidemia
- No uncontrolled diabetes mellitus
- No active hepatitis B and C infection within 24 weeks prior to study entry
ACTG A5332/REPRIEVE (Pitavastatin)
This is a randomized blinded study to see if Pitavastatin can prevent heart disease and heart disease related deaths in people with HIV infection who are taking medications. Participant will be randomized to either Pitavastatin 4mg one pill daily or Placebo Pitavastatin on pill daily. Once enrolled, participants will take the drug/placebo for up to 6 years. Participants will be seen every 4 months. Subjects enrolled in the main study will have the option of enrolling into the sub-study, which includes a cardiac CT scan. This is a study that will enroll 6500 people from several countries.
Purpose
The main purpose of this study is to determine the effects of Pitavastatin as a primary prevention strategy for major adverse cardiovascular events (MACE) in HIV.
Requirements
- HIV-infected men and women between 40 and 75 yrs of age
- Continuous ART for at least 6 months prior to study entry
- CD4+ cell count >100 cells/mm3
- No prior use of a statin drug
- No history of atherosclerotic cardiovascular disease (heart attack, stroke etc.)
ACTG A5329 (Chronic Hepatitis C)
This trial is non-randomized, and an open label phase II study of Interferon-free therapy for Chronic Hepatitis C genotype 1 in persons with HIV-1 Co Infection receiving concurrent ART. The study drugs that will be provided are: ABT-450/r/ABT-267 (150/100/25 mg) po daily plus ABT-333 (250mg) po twice a day plus Ribavirin 1000-1200mg (based on weight) divided into 2 doses (twice a day). Subjects will be treated for either 12 or 14 weeks, but neither subjects nor providers will be able to choose duration of treatment. All subjects will be followed up to 48 weeks on study.
Purpose
The study is to evaluate the safety and tolerability of DAA+RBV therapy in subjects coinfected with HIV-1, to estimate the efficacy of DAA+RBV therapy in treatment-naïve HCV/HIV-1 coinfected subjects, as measured by the sustained virologic response at 12 weeks (SVR12) after DAA+RBV therapy discontinuation, where SVR12 is defined as HCV RNA in the blood less than the assay lower limit of quantification.
Requirements
- HIV- and HCV-infected persons 18-70 years of age
- CD4+ cell count ≥200 cells/uL and CD4+ cell percentage ≥14%
- HIV-1 viral load <50 copies/ml
- No genotypic resistance to any ARV agent prior to study entry.
- HCV genotype 1 infection and HCV viral load > 10,000 IU/mL
Must be on one of the following ARV regimens: Tenofovir plus emtricitabine once daily (or fixed-dose combination Truvada) or tenofovir plus lamivudine once a day ( or fixed combination TDF/3TC) PLUS raltegravir 400 mg twice a day or darunavir 800 mg once a day administered with ritonavir 100 mg once a day.
ACTG A5327 (Ledipasvir/Sofosbuvir)
This study is for HIV/HCV coinfected individuals. Participants must have a new HCV infection (<24 weeks prior to initial A5327 screening). It is an open-label study using the new drugs Ledipasvir (LDV) and Sofosbuvir (SOF) in a fixed-dose combination (Ledipasvir 90/Sofosbuvir 400mg tablet). Participants will receive 8 weeks of the drug and be followed up for 24 weeks.
Purpose
The study is to evaluate HCV treatment response to SOF and daily LDV/SOF taken for 8 weeks as assessed by SVR12, defined as HCV RNA undetectable 12 weeks post-treatment in persons with existing HIV-1 infection who are acutely infected with HCV genotype 1 or 4.
Requirements
- HIV-infected men and women age ≥18 years
- CD4+ cell count >200 cells/mm3
- HIV-1 RNA level <50 copies/mL
- No infection with hepatitis B virus
- No prior history of G-I disorder that could interfere with the absorption of the study drug
ACTG A5353 (Dolutegravir + Lamivudine)
This study is for HIV treatment-naive individuals. Participants must have no previous ARV treatment at any time prior to study entry. It is a phase II, single-arm, open-label, pilot study of dolutegravir (DTG) plus lamivudine (3TC). A total of 120 participants will be enrolled and followed for 52 weeks.
Purpose
The main purpose of this study is to estimate the virologic success rate after initiating DTG plus 3TC, to evaluate the safety and tolerability of DTG plus 3TC.
Requirements
- HIV-infected men and women age ≥18 years
- Plasma HIV-1 RNA ≥1000 copies/mL and <500,000 copies/Ml
- ARV treatment drug-naive
- Hepatitis B surface antigen negative within 45 days prior to study entry
- No Active hepatitis C virus treatment or anticipated need for treatment within study period
Studies for People Who Have Never Taken HIV Medication
ACTG A5353 (Dolutegravir + Lamivudine)
This study is for HIV treatment-naive individuals. Participants must have no previous ARV treatment at any time prior to study entry. It is a phase II, single-arm, open-label, pilot study of dolutegravir (DTG) plus lamivudine (3TC). A total of 120 participants will be enrolled and followed for 52 weeks.
Purpose
The main purpose of this study is to estimate the virologic success rate after initiating DTG plus 3TC, to evaluate the safety and tolerability of DTG plus 3TC.
Requirements
- HIV-infected men and women age ≥18 years
- Plasma HIV-1 RNA ≥1000 copies/mL and <500,000 copies/Ml
- ARV treatment drug-naive
- Hepatitis B surface antigen negative within 45 days prior to study entry
- No active hepatitis C virus treatment or anticipated need for treatment within study period
Studies Involving the HPV Vaccine for Women
No studies are currently available.
Studies of HIV/HCV
ACTG A5329 (Chronic Hepatitis C)
This trial is non-randomized, and an open label phase II study of Interferon-free therapy for Chronic Hepatitis C genotype 1 in persons with HIV-1 Co Infection receiving concurrent ART. The study drugs that will be provided are: ABT-450/r/ABT-267 (150/100/25 mg) po daily plus ABT-333 (250mg) po twice a day plus Ribavirin 1000-1200mg (based on weight) divided into 2 doses (twice a day). Subjects will be treated for either 12 or 14 weeks, but neither subjects nor providers will be able to choose duration of treatment. All subjects will be followed up to 48 weeks on study.
Purpose
The study is to evaluate the safety and tolerability of DAA+RBV therapy in subjects coinfected with HIV-1, to estimate the efficacy of DAA+RBV therapy in treatment-naïve HCV/HIV-1 coinfected subjects, as measured by the sustained virologic response at 12 weeks (SVR12) after DAA+RBV therapy discontinuation, where SVR12 is defined as HCV RNA in the blood less than the assay lower limit of quantification.
Requirements
- HIV- and HCV-infected persons 18-70 years of age
- CD4+ cell count ≥200 cells/uL and CD4+ cell percentage ≥14%
- HIV-1 viral load <50 copies/ml
- No genotypic resistance to any ARV agent prior to study entry.
- HCV genotype 1 infection and HCV viral load > 10,000 IU/mL
Must be on one of the following ARV regimens: Tenofovir plus emtricitabine once daily (or fixed-dose combination Truvada) or tenofovir plus lamivudine once a day (or fixed combination TDF/3TC) PLUS raltegravir 400 mg twice a day or darunavir 800 mg once a day administered with ritonavir 100 mg once a day.
ACTG A5327 (Ledipasvir/Sofosbuvir)
This study is for HIV/HCV coinfected individuals. Participants must have a new HCV infection (<24 weeks prior to initial A5327 screening). It is an open-label study using the new drugs Ledipasvir (LDV) and Sofosbuvir (SOF) in a fixed-dose combination (Ledipasvir 90/Sofosbuvir 400mg tablet). Participants will receive 8 weeks of the drug and be followed up for 24 weeks.
Purpose
The study is to evaluate HCV treatment response to SOF and daily LDV/SOF taken for 8 weeks as assessed by SVR12, defined as HCV RNA undetectable 12 weeks post-treatment in persons with existing HIV-1 infection who are acutely infected with HCV genotype 1 or 4.
Requirements
- HIV infected men and women age ≥18 years
- CD4+ cell count >200 cells/mm3
- HIV-1 RNA level <50 copies/mL
- No infection with hepatitis B virus
- No prior history of G-I disorder that could interfere with the absorption of the study drug
Studies of Switching or Restarting Medication
No studies are currently available.
Vaccine Studies
No studies are currently available.
Immune Activation Studies
ACTG A5314 (Low Dose Methotrexate/FMD)
This is a phase II, randomized double blind, placebo-controlled trial to evaluate the safety and efficacy of Low Dose Methotrexate (LDMTX) on endothelial function, assessed by flow-mediated vasodilatation (FMD) of the brachial artery. Key inflammatory markers of CVD risk and T-Cell activation in the blood, and size of the HIV reservoir will be measured during the study. Subjects will be randomized to receive LDMTX or matching placebo. Subjects will take 5mg x 1 wk, 10mg x 11 wks and 15mg x 12 wks totally 24 weeks of drug/placebo followed by observation for an additional 12 weeks. This is a 24-week study.
Purpose
This study will assess the safety and effects of LDMTX on endothelial function (assessed by flow-mediated vasodilation of the brachial artery), key inflammatory markers of cardiovascular disease risk (high-sensitivity C-reactive protein), interleukin-6, soluble CD163 (sCD163), D-dimer, T-cell and monocyte activation in the blood, and size of the HIV reservoir.
Requirements
- HIV+ men and women (not of childbearing potential) ≥ 40 yrs of age
- Continuous ART for ≥24 weeks prior to study entry
- CD4+ T-cell count ≥400 cells/mm3 obtained within 60 days prior to study entry
- HIV-1 RNA level <20 copies/mL for at least 24 weeks prior to study entry
- Documented CVD or increased risk for CVD
- Any one of the following CVD risk factors:
- CAD
- Cerebrovascular disease
- Peripheral arterial disease
- Controlled diabetes
- Current smoking: Subject report of smoking at least a half a pack of cigarettes a day, on average, in the past month
- Hypertension
- Dyslipidemia
- No uncontrolled diabetes mellitus
- No active hepatitis B and C infection within 24 weeks prior to study entry
ACTG A5315 (Romidepsin RMD)
This is a phase I/II safety, dose-escalation, and preliminary efficacy study of romidepsin (RMD), a histone deacetylase inhibitor, in HIV-infected subjects with suppressed viremia on a PI-sparing regimen. Subjects will complete the study in 4 to 8 weeks. Participants will be admitted to the inpatient Clinical Research Unit and will be compensated for their time.
Purpose
The overall goal of this exploratory study is to identify single doses of RMD that are safe and well-tolerated in HIV-infected subjects with HIV-1 RNA levels < 50 copies/mL on a stable ART regimen and to assess the induction of HIV-1 expression in HIV-infected subjects with suppressed viremia by measuring plasma viremia using a single copy HIV-1 RNA assay prior to RMD dosing and at other defined time points after initiation of RMD dosing.
Requirements
- Documented HIV infection and ≥ 18 years of age
- CD4+counts > 300 cells/mm3, HIV-1 RNA levels < 50 copies/mL and no blips > 50 copies/mL for past
24 months, HIV-1 RNA level > 0.4 copies/mL by single-copy assay (SCA) - Negative HCV Antibody and HBsAg results within 90 to 50 days prior to study entry
- No history of or current malignancy requiring cytotoxic therapy
- No history of seizure disorders
ACTG A5325 (Isotretinoin)
This study is an open-label, randomized, two arm pilot trial of isotretinoin therapy to compare the changes in expression levels of CD38/HLA-DR on CD8+ T cells after 16 weeks of treatment followed by 12 weeks of observation on ART alone. Arm A (Treatment) will receive isotretinoin at approximately 0.5mg/kg po once daily for 4 weeks, then increased to approximately 1.0 mg/kg po once daily for 12 weeks or Arm B (Control) No treatment. This is a 28-week study.
Purpose
The main purpose of the study is to evaluate the effect of isotretinoin on changes in expression levels of CD38/HLA-DR on CD8+ T cells, the safety and tolerability of isotretinoin in HIV-infected participants on antiretroviral therapy (ART).
Requirements
- Documented HIV infection, men and post-menopausal females≥ 18 years of age
- HIV-1 RNA < 75 copies/mL
- No active hepatitis B or C
- No history of diabetes
- No severe psychiatric disorders
- Willingness to adhere to the IPledge program (on-line program for dispensing isotretinoin and preventing pregnancy).
ACTG A5330s (Gut Mucosa/Colonoscopies/Biopsies)
This is a sub-study of A5325. It will evaluate the change in CD4+ Tcell percentage in the lining of the intestines. Samples will be collected via colonoscopy with biopsies immediately prior to the start of A5325 study treatment and followed its completion at week 16. Nationally, targeted enrollment is 30 subjects.
Purpose
The main purpose of the study is to evaluate change in CD4+ T cell reconstitution in the lining of the intestines after treatment with isotretinoin.
Requirements
- Must be enrolled in A5325
- Commitment to two colonoscopies with biopsies within a 4-month period and who have no contraindications for colonoscopy