ACTG - Aids Clinical Trial Group

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The Joint Clinical Research Centre, AIDS Clinical Trial Group, Clinical Research Site conducts clinical trials offering experimental treatments against HIV/AIDS and AIDS-related opportunistic infections. The trials are open to HIV-infected adults at all stages of HIV disease. Study medications are in most cases provided free of charge.

The JCRC CRS is a member of the AIDS Clinical Trial Group supported by funds from the National Institute of Allergy and Infectious Diseases (NIAID) in Washington, D.C.

To find out more about the ACTG click here: https://actgnetwork.org/

Protocols

A5288:Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy after Viral Failure (MULTI-OCTAVE)

This is an open-label study being conducted in resource-limited settings (RLS) for HIV-infected participants who are failing their current second-line PI-based regimen  and who have  triple-class experience or resistance [i.e., documented experience with or demonstrated resistance tonucleoside reverse  transcriptase inhibitors (NRTIs), non-NRITs (NNRTIs), protease inhibitors (PIs)]. We will evaluate the use of novel agents and contemporary management tools that include standard genotyping, plasma viral load (VL) monitoring and a cell phone-based adherence intervention. Antiretroviral (ARV) history and the results of a screening genotype will be used to place participants into one of four treatment cohorts.The adherence component of the study consists of a randomized comparison of local standard-of-care (SOC) adherence procedures vs. SOC plus cell phone-based adherence intervention (CPI).

This study is closed to enrolment.

A5264: A Randomized Evaluation of Antiretroviral Therapy Alone or with Delayed Chemotherapy versus Antiretroviral Therapy with Immediate Adjunctive Chemotherapy for Treatment of Limited Stage AIDS-KS in Resource-Limited Settings (REACT-KS)

A phase III open label randomized clinical trial to compare the efficacy and safety of ART alone or with delayed chemotherapy (Etoposide) to ART with immediate Etoposide for initial treatment of limited stage AIDS- related Kaposi’s Sarcoma in individuals who have never been treated for KS and who are currently not receiving ART.

This study is closed to enrolment.

A5243: Plan for Obtaining Human Biological Samples at Non-U.S. Clinical Research Sites for Currently Unspecified Genetic Analyses

This is an observational study designed to obtain saliva and blood samples from all current and former participants in ACTG clinical trials at non-U.S. clinical research sites. These samples will serve as a source for DNA that will be stored for future genetic studies. This DNA will only be used for studies relevant to HIV and its complications.  Even after a DNA sample is stored, its use for any future genetic study will require additional review and approval through ACTG procedures that include review by the site’s IRB or REC. These ACTG procedures are described in detail in the A5243 Standard Operating Procedure, a document that can be found on the study’s protocol-specific web page on the ACTG Website. This study is only open to non-US ACTG sites.

Study entry requirements:

  • HIV-1 infected
  • Current or past participation in an ACTG trial conducted at the JCRC.

UPCOMING PROTOCOLS – not yet open to enrollment:

A5349:TBTC S31 Rifapentine-Containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-Label, Controlled Phase 3 Clinical Trial

This is an international, multicenter, randomized, controlled, open-label, 3-arm, phase 3 non-inferiority trial.Standard TB treatment takes 6 months. Stronger drugs might allow treatment to be shorter. Two new drugs are called rifapentine and moxifloxacin these drugs look stronger than standard drugs in international research studies. This study tests if they are strong enough to make TB treatment shorter.  This study will also look at what side effects are caused by taking rifapentine and moxifloxacin for 4 months.

Study entry requirements:

  • HIV-1 infected and uninfected
  • ≥18 years of age
  • TB Treatment naïve
  • Screening VL must be 1000 to ≤ 500,000 c/mL

A5332:Randomized Trial to Prevent Vascular Events in HIV – REPRIEVE

HIV causes inflammation inside the body, which can contribute to diseases such as heart disease. HIV medications can lower inflammation somewhat, but levels of inflammation can remain higher compared to people who are not infected with HIV. Statins are used to lower cholesterol and levels of triglycerides, but some clinical trials have shown that statins may have other benefits. Pitavastatin is a statin used to treat high cholesterol and lowers triglyceride levels in the blood. The purpose of this study is to see if Pitavastatin can prevent heart disease and heart disease related deaths in people with HIV infection who are taking HIV medications. This is a 6 year study with participants randomized to Pitavastatin or a placebo.

Study entry requirements:

  • HIV-1 infected
  • men and women between the ages of 40 and 75 (women cannot be pregnant)
  • On ARTs for at least 6 months prior to study entry
  • CD4+ cell count >100
  • No history of cardiovascular disease (history of heart attack, stroke, etc.)
  • No history of cancer in the last 3 years
  • Not currently using statins

A5345:Identification of Biomarkers to Predict Time to Plasma HIV RNA Rebound and Post-Treatment Viral Control during an Intensively Monitored Antiretroviral Pause (IMAP)

This study uses an intensively monitored antiretroviral pause (IMAP) to establish a carefully controlled setting for the study of viral rebound and re-suppression in virologically well suppressed participants who were originally treated during either acute or chronic HIV infection.  Large volume blood draws and leukapheresis will allow the evaluation of a range of biomarkers and the validation of future assays for predicting the timing of HIV rebound. During the IMAP phase of this study, participants will have frequent study visits, beginning at twice per week, with well delineated criteria for resuming ART.  Testing will include HIV-1 RNA, CD4 and immunologic, virologic, and pharmacologic assays.  A substudy, A5347s, will evaluate rectal biopsies and potentially other tissue compartments.

Study entry requirements:

  • HIV-1 infected
  • Men and women between the ages of 18 and 70 years
  • Continuous ART for at least 2 years with any NNRTI-, PI-, or INSTI-containing regimen.
  • Screening CD4 > 500
  • HIV-1 RNA suppression for > 24 months
  • Chronic HCV and HBV are exclusionary

A5354:Effect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on Measures of HIV-1 Persistence and on HIV-1 Specific Immune Responses

This is a Phase II, prospective, open-label study to measure the effects of early antiretroviral therapy (ART) on the establishment of HIV-1 reservoir and HIV-1-specific immunity. Participants with acute HIV-1 infection will have an enrollment visit that will include the immediate initiation of ART. 

Study entry requirements:

  • Acute HIV-1 infection
  • Men and women age 18 and above

JCRC CRS Community Advisory Board

The JCRC Community Advisory Board (CAB) has the distinction of being the first Biomedical Institutional Research CAB on the African continent. The CAB was established in 1990 to support the first Phase I HIV-1 Vaccine Trial to be conducted in Africa. This trial was conducted at JCRC.

Mission of the CAB:

The Mission of the JCRC CAB is to “Link, Advise and Educate the community and researchers on involvement in HIV/AIDS Research that is relevant to the people of Uganda CAB. The CAB Liaison officer can be reached on 0417 723 000 ext. 3083 or via email:  jmukasa@jcrc.org.ug

One can also, visit the ACTG website for more information.

Purpose of the CAB:

The CAB provides an opportunity for affected communities to:

  • Participate in the development of new protocols
  • Play an advocacy role on behalf of the community
  • Provide information to the communities about upcoming and ongoing protocols
  • Voice concerns regarding specific clinical studies, their development, implementation and outcomes to the clinical investigators
  • Perform outreaches to the  community on the challenges of HIV/AIDS

Contact Us

If you would like more information about the trials at our site please contact us:

  • Post: P.O. Box 10005, Kampala