HIV InfectionsNCT00096824
A Study of Dementia and Neurological Problems in HIV Infected Patients Who Are Participating in ACTG A5175
An observational study of HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 11 sites in 5 countries.
Trial summary
The purpose of this study is to determine how often dementia and other neurological problems occur in people with HIV. Participants of ACTG A5175 will enroll in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Neurological assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 860 participants
- Where
- 11 sitesin 5 countries
- Study dates
- Feb 2006to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants who enrolled in ACTG study 5175
Who may be able to join
- HIV-1 infected
- Prior antiretroviral therapy for less than 7 days any time prior to study entry
- CD4 count less than 300 cells/mm3
- Willing to use acceptable means of contraception
- Plans to stay in the area for the duration of study participation
- Willing to adhere to study follow-up schedule for ACTG A5175 and this study
- Have not begun ACTG A5175 antiretroviral therapy, but planning to start therapy after enrolling in this study
Who cannot join
- Any active severe psychiatric illness (e.g., schizophrenia, severe depression, severe bipolar affective disorder) that, in the opinion of the site investigator, may interfere with the study results
- Current drug or alcohol abuse that, in the opinion of the site investigator, would interfere with study requirements
- Serious illness or hospitalization that, in the opinion of the site investigator, may interfere with the study results
- Any condition that, in the opinion of the site investigator, would interfere with study requirements
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
India4 sites
YRG Center for AIDS Research and Education
Chennai, 60001-7
Dr. Kotnis Dispensary
Pune, 411026
National AIDS Research Institute (NARI) ICMR
Pune, 411026
National Institute of Virology (NARI)
Pune, 411026
Brazil2 sites
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 91350-200
Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz
Rio de Janeiro, 21045-900
Malawi2 sites
The Johns Hopkins-Malawi College of Medicine Project
Blantyre
University of North Carolina Project (UNC Project)
Lilongwe
South Africa2 sites
University of KwaZulu Natal
Durban, KwaZulu-Natal, 4013
University of Witwatersrand
Johannesburg
About this study
Official title: International Neurological Study: A Stand Alone Study for Participants of A5175 (A Phase IV, Randomized, Open-Label Evaluation of the Efficacy of Once-Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Therapy Combination for Initial Treatment of HIV-1 Infected Individuals From Diverse Areas of the World)
The purpose of this study is to determine how often dementia and other neurological problems occur in people with HIV. Participants of ACTG A5175 will enroll in this study.
Read the detailed description
Both the central and peripheral nervous systems (CNS and PNS) are affected by HIV; however, the causes of neurotoxicity in HIV infected patients are unknown. Initial data indicate that as many as 40% of patients with HIV develop some form of dementia. Other common neurological problems observed in HIV patients are peripheral neuropathy and opportunistic infections of the CNS. Most antiretroviral drugs used in the treatment of HIV have poor penetration into the CNS, which may explain how HIV persists in the CNS and contributes to the prevalence of dementia and other neurological disorders in HIV infected patients. This study will examine the prevalence of dementia and other neurological disorders in participants in ACTG A5175, "Once-Daily PI/NNRTI Therapy Combinations for Treatment Naive, HIV Infected Patients in Resource-limited Conditions."
The study will last approximately 2.5 to 3 years. Participants will undergo neurological examinations and neuropsychological assessments at entry to both steps of ACTG A5175 and before the administration of the new antiretroviral regimen, then every 24 weeks until they discontinue ACTG A5175. Physicians will make targeted diagnoses at each study visit.
- Conditions
- HIV Infections
- Being tested
- Neurological assessment
- Keywords
- Acute Infection, Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological assessmentBehavioural
All participants will undergo neurological examinations and neuropsychological assessments.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Participants will undergo neurological examinations and neuropsychological assessments at entry to both steps of ACTG A5175 and before the administration of the new antiretroviral regimen, then every 24 weeks until they discontinue ACTG A5175. Physicians will make targeted diagnoses at each study visit. Receives: Behavioral: Neurological assessment |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2004 (estimated)
- Study startFeb 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 860 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Kevin Robertson, PhD, Study chair, Department of Neurology, University of North Carolina at Chapel HillJohnstone Kumwenda, MD, MBBS, MMED, Study chair, Internal Medicine, Johns Hopkins ProjectKhuanchai Supparatpinyo, MD, Study chair, Research Institute for Health Sciences, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096824
- Sponsor's protocol ID
- ACTG A5199
- Other IDs
- 1U01AI068636
- Status last verified
- Mar 2015
- First submitted
- 15 Nov 2004
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Albright AV, Soldan SS, Gonzalez-Scarano F. Pathogenesis of human immunodeficiency virus-induced neurological disease. J Neurovirol. 2003 Apr;9(2):222-7. doi: 10.1080/13550280390194073.
PubMed 12707852McArthur JC, Haughey N, Gartner S, Conant K, Pardo C, Nath A, Sacktor N. Human immunodeficiency virus-associated dementia: an evolving disease. J Neurovirol. 2003 Apr;9(2):205-21. doi: 10.1080/13550280390194109.
PubMed 12707851Sacktor N. The epidemiology of human immunodeficiency virus-associated neurological disease in the era of highly active antiretroviral therapy. J Neurovirol. 2002 Dec;8 Suppl 2:115-21. doi: 10.1080/13550280290101094.
PubMed 12491162Sacktor N, McDermott MP, Marder K, Schifitto G, Selnes OA, McArthur JC, Stern Y, Albert S, Palumbo D, Kieburtz K, De Marcaida JA, Cohen B, Epstein L. HIV-associated cognitive impairment before and after the advent of combination therapy. J Neurovirol. 2002 Apr;8(2):136-42. doi: 10.1080/13550280290049615.
PubMed 11935465Michael H, Rapulana A, Smit T, Xulu N, Danaviah S, Ramlall S, Oosthuizen F. Dual Trajectories of Serum Brain-Derived Neurotrophic Factor and Cognitive Function in People Living with HIV. Res Sq [Preprint]. 2025 Apr 14:rs.3.rs-4307577. doi: 10.21203/rs.3.rs-4307577/v1.
PubMed 40321763Michael HU, Rapulana AM, Smit T, Xulu N, Danaviah S, Ramlall S, Oosthuizen F. Dual trajectories of serum brain-derived neurotrophic factor and cognitive function in people living with HIV. Sci Rep. 2025 May 3;15(1):15520. doi: 10.1038/s41598-025-99569-6.
PubMed 40319152Robertson KR, Jiang H, Kumwenda J, Supparatpinyo K, Marra CM, Berzins B, Hakim J, Sacktor N, Campbell TB, Schouten J, Mollan K, Tripathy S, Kumarasamy N, La Rosa A, Santos B, Silva MT, Kanyama C, Firhnhaber C, Murphy R, Hall C, Marcus C, Naini L, Masih R, Hosseinipour MC, Mngqibisa R, Badal-Faesen S, Yosief S, Vecchio A, Nair A; AIDS Clinical Trials Group. Human Immunodeficiency Virus-associated Neurocognitive Impairment in Diverse Resource-limited Settings. Clin Infect Dis. 2019 May 2;68(10):1733-1738. doi: 10.1093/cid/ciy767.
PubMed 30219843Robertson KR, Oladeji B, Jiang H, Kumwenda J, Supparatpinyo K, Campbell TB, Hakim J, Tripathy S, Hosseinipour MC, Marra CM, Kumarasamy N, Evans S, Vecchio A, La Rosa A, Santos B, Silva MT, Montano S, Kanyama C, Firnhaber C, Price R, Marcus C, Berzins B, Masih R, Lalloo U, Sanne I, Yosief S, Walawander A, Nair A, Sacktor N, Hall C; 5199 Study Team; and the AIDS Clinical Trials Group. Human Immunodeficiency Virus Type 1 and Tuberculosis Coinfection in Multinational, Resource-limited Settings: Increased Neurological Dysfunction. Clin Infect Dis. 2019 May 2;68(10):1739-1746. doi: 10.1093/cid/ciy718.
PubMed 30137250Robertson K, Jiang H, Kumwenda J, Supparatpinyo K, Evans S, Campbell TB, Price R, Tripathy S, Kumarasamy N, La Rosa A, Santos B; 5199 study team; Silva MT, Montano S, Kanyama C, Faesen S, Murphy R, Hall C, Marra CM, Marcus C, Berzins B, Allen R, Housseinipour M, Amod F, Sanne I, Hakim J, Walawander A, Nair A; AIDS Clinical Trials Group. Improved neuropsychological and neurological functioning across three antiretroviral regimens in diverse resource-limited settings: AIDS Clinical Trials Group study a5199, the International Neurological Study. Clin Infect Dis. 2012 Sep;55(6):868-76. doi: 10.1093/cid/cis507. Epub 2012 Jun 1.
PubMed 22661489
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Neurological Study: A Stand Alone Study for Participants of A5175 (A Phase IV, Randomized, Open-Label Evaluation of the Efficacy of Once-Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Therapy Combination for Initial Treatment of HIV-1 Infected Individuals From Diverse Areas of the World)
- ClinicalTrials.gov ID
- NCT00096824
- Acronym / sponsor ID
- ACTG A5199
- Conditions
- HIV Infections
- Keywords
- Acute Infection, Treatment Naive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 860 participants (actual)
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH)
- Study start
- Feb 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 16 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine how often dementia and other neurological problems occur in people with HIV. Participants of ACTG A5175 will enroll in this study.
Detailed description
Both the central and peripheral nervous systems (CNS and PNS) are affected by HIV; however, the causes of neurotoxicity in HIV infected patients are unknown. Initial data indicate that as many as 40% of patients with HIV develop some form of dementia. Other common neurological problems observed in HIV patients are peripheral neuropathy and opportunistic infections of the CNS. Most antiretroviral drugs used in the treatment of HIV have poor penetration into the CNS, which may explain how HIV persists in the CNS and contributes to the prevalence of dementia and other neurological disorders in HIV infected patients. This study will examine the prevalence of dementia and other neurological disorders in participants in ACTG A5175, "Once-Daily PI/NNRTI Therapy Combinations for Treatment Naive, HIV Infected Patients in Resource-limited Conditions."
The study will last approximately 2.5 to 3 years. Participants will undergo neurological examinations and neuropsychological assessments at entry to both steps of ACTG A5175 and before the administration of the new antiretroviral regimen, then every 24 weeks until they discontinue ACTG A5175. Physicians will make targeted diagnoses at each study visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Neurological assessmentParticipants will undergo neurological examinations and neuropsychological assessments at entry to both steps of ACTG A5175 and before the administration of the new antiretroviral regimen, then every 24 weeks until they discontinue ACTG A5175. Physicians will make targeted diagnoses at each study visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants who enrolled in ACTG study 5175
Key inclusion criteria (7 listed)
- HIV-1 infected
- Prior antiretroviral therapy for less than 7 days any time prior to study entry
- CD4 count less than 300 cells/mm3
- Willing to use acceptable means of contraception
- Plans to stay in the area for the duration of study participation
Key exclusion criteria (4 listed)
- Any active severe psychiatric illness (e.g., schizophrenia, severe depression, severe bipolar affective disorder) that, in the opinion of the site investigator, may interfere with the study results
- Current drug or alcohol abuse that, in the opinion of the site investigator, would interfere with study requirements
- Serious illness or hospitalization that, in the opinion of the site investigator, may interfere with the study results
- Any condition that, in the opinion of the site investigator, would interfere with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurological assessmentAll participants will undergo neurological examinations and neuropsychological assessments. | Behavioural | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Background: PubMed 12707852Albright AV, Soldan SS, Gonzalez-Scarano F. Pathogenesis of human immunodeficiency virus-induced neurological disease. J Neurovirol. 2003 Apr;9(2):222-7. doi: 10.1080/13550280390194073.
- Background: PubMed 12707851McArthur JC, Haughey N, Gartner S, Conant K, Pardo C, Nath A, Sacktor N. Human immunodeficiency virus-associated dementia: an evolving disease. J Neurovirol. 2003 Apr;9(2):205-21. doi: 10.1080/13550280390194109.
- Background: PubMed 12491162Sacktor N. The epidemiology of human immunodeficiency virus-associated neurological disease in the era of highly active antiretroviral therapy. J Neurovirol. 2002 Dec;8 Suppl 2:115-21. doi: 10.1080/13550280290101094.
- Background: PubMed 11935465Sacktor N, McDermott MP, Marder K, Schifitto G, Selnes OA, McArthur JC, Stern Y, Albert S, Palumbo D, Kieburtz K, De Marcaida JA, Cohen B, Epstein L. HIV-associated cognitive impairment before and after the advent of combination therapy. J Neurovirol. 2002 Apr;8(2):136-42. doi: 10.1080/13550280290049615.
- Derived from this study: PubMed 40321763Michael H, Rapulana A, Smit T, Xulu N, Danaviah S, Ramlall S, Oosthuizen F. Dual Trajectories of Serum Brain-Derived Neurotrophic Factor and Cognitive Function in People Living with HIV. Res Sq [Preprint]. 2025 Apr 14:rs.3.rs-4307577. doi: 10.21203/rs.3.rs-4307577/v1.
- Derived from this study: PubMed 40319152Michael HU, Rapulana AM, Smit T, Xulu N, Danaviah S, Ramlall S, Oosthuizen F. Dual trajectories of serum brain-derived neurotrophic factor and cognitive function in people living with HIV. Sci Rep. 2025 May 3;15(1):15520. doi: 10.1038/s41598-025-99569-6.
- Derived from this study: PubMed 30219843Robertson KR, Jiang H, Kumwenda J, Supparatpinyo K, Marra CM, Berzins B, Hakim J, Sacktor N, Campbell TB, Schouten J, Mollan K, Tripathy S, Kumarasamy N, La Rosa A, Santos B, Silva MT, Kanyama C, Firhnhaber C, Murphy R, Hall C, Marcus C, Naini L, Masih R, Hosseinipour MC, Mngqibisa R, Badal-Faesen S, Yosief S, Vecchio A, Nair A; AIDS Clinical Trials Group. Human Immunodeficiency Virus-associated Neurocognitive Impairment in Diverse Resource-limited Settings. Clin Infect Dis. 2019 May 2;68(10):1733-1738. doi: 10.1093/cid/ciy767.
- Derived from this study: PubMed 30137250Robertson KR, Oladeji B, Jiang H, Kumwenda J, Supparatpinyo K, Campbell TB, Hakim J, Tripathy S, Hosseinipour MC, Marra CM, Kumarasamy N, Evans S, Vecchio A, La Rosa A, Santos B, Silva MT, Montano S, Kanyama C, Firnhaber C, Price R, Marcus C, Berzins B, Masih R, Lalloo U, Sanne I, Yosief S, Walawander A, Nair A, Sacktor N, Hall C; 5199 Study Team; and the AIDS Clinical Trials Group. Human Immunodeficiency Virus Type 1 and Tuberculosis Coinfection in Multinational, Resource-limited Settings: Increased Neurological Dysfunction. Clin Infect Dis. 2019 May 2;68(10):1739-1746. doi: 10.1093/cid/ciy718.
- Derived from this study: PubMed 22661489Robertson K, Jiang H, Kumwenda J, Supparatpinyo K, Evans S, Campbell TB, Price R, Tripathy S, Kumarasamy N, La Rosa A, Santos B; 5199 study team; Silva MT, Montano S, Kanyama C, Faesen S, Murphy R, Hall C, Marra CM, Marcus C, Berzins B, Allen R, Housseinipour M, Amod F, Sanne I, Hakim J, Walawander A, Nair A; AIDS Clinical Trials Group. Improved neuropsychological and neurological functioning across three antiretroviral regimens in diverse resource-limited settings: AIDS Clinical Trials Group study a5199, the International Neurological Study. Clin Infect Dis. 2012 Sep;55(6):868-76. doi: 10.1093/cid/cis507. Epub 2012 Jun 1.
- Click here for more information about the ACTG A5175 studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Robertson, PhD study chair
Department of Neurology, University of North Carolina at Chapel Hill
Johnstone Kumwenda, MD, MBBS, MMED study chair
Internal Medicine, Johns Hopkins Project
Khuanchai Supparatpinyo, MD study chair
Research Institute for Health Sciences, Chiang Mai University
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 11 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in India, Brazil, Malawi, South Africa, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00096824, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.