AzTrials
AzTrials

HIV InfectionsPhase 2NCT00036452

A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation

A Phase 2 study testing lopinavir/ritonavir, emtricitabine and stavudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 29 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Anti-HIV drug therapy works best when the drugs are taken exactly as prescribed by a doctor. Because anti-HIV therapy often involves multiple drugs, some people have difficulty taking them all correctly. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
HIV Infections
What is being tested?
lopinavir/ritonavir, emtricitabine and stavudine
How many people
402 participants
Where
29 sitesin 3 countries
Study dates
Start not givento Jan 2006
Phase
Phase 2
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 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • HIV infection
  • Age 13 years or older and have written consent of guardian if under 18
  • Weigh at least 88 pounds
  • Viral load of 2000 copies/ml or more within 90 days before study entry
  • Have not taken anti-HIV drugs for more than 7 days
  • Agree to use acceptable methods of contraception during the study and for 1 month after stopping the study drugs

Who cannot join

  • Pregnant or breastfeeding
  • In jail
  • Sensitive or allergic to any part of the study drugs
  • Treated with acute systemic therapy for a serious infection or other serious medical illness within 7 days prior to study entry, unless the participant has completed 7 days of therapy and is clinically stable
  • Recent serious illness, including pancreatitis or peripheral neuropathy
  • Alcohol or illicit drug abuse
Show all 9Show fewer
  • Taken any of the following within 14 days before study entry: investigational drugs, anti-HIV vaccines, drugs that may cause pancreatitis or peripheral neuropathy, or drugs that are associated with CYP3A
  • Treated for cancer (not including minimal Kaposi's sarcoma) within 30 days before study entry
  • History of mental illness that might interfere with the study

Trial locations and contacts

29 sites in 3 countries.

29 sites in 3 countries

United States27 sites

  • University of Colorado Hospital CRS

    Aurora, Colorado, 80262

  • IHV Baltimore Treatment CRS

    Baltimore, Maryland, 21201

  • Johns Hopkins Adult AIDS CRS

    Baltimore, Maryland, 21287

  • Unc Aids Crs

    Chapel Hill, North Carolina, 27514

  • Univ. of Cincinnati CRS

    Cincinnati, Ohio, 45267-0405

  • MetroHealth CRS

    Cleveland, Ohio, 44109-1998

  • The Ohio State Univ. AIDS CRS

    Columbus, Ohio

  • SSTAR, Family Healthcare Ctr.

    Fall River, Massachusetts

  • Regional Center for Infectious Disease, Wendover Medical Center CRS

    Greensboro, North Carolina, 27401-1004

  • Univ. of Hawaii at Manoa, Leahi Hosp.

    Honolulu, Hawaii, 96816-2396

  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic

    Indianapolis, Indiana, 46202-5250

  • USC CRS

    Los Angeles, California, 90033-1079

  • Univ. of Miami AIDS CRS

    Miami, Florida, 33136

  • University of Minnesota, ACTU

    Minneapolis, Minnesota, 55455-0392

  • Vanderbilt Therapeutics CRS

    Nashville, Tennessee, 37203

  • Beth Israel Med. Ctr., ACTU

    New York, New York, 10003

  • NY Univ. HIV/AIDS CRS

    New York, New York, 10016

  • Hosp. of the Univ. of Pennsylvania CRS

    Philadelphia, Pennsylvania, 19104

  • Pitt CRS

    Pittsburgh, Pennsylvania, 15213-2582

  • The Miriam Hosp. ACTG CRS

    Providence, Rhode Island, 02906

  • Wake County Health and Human Services CRS

    Raleigh, North Carolina

  • Univ. of Rochester ACTG CRS

    Rochester, New York, 14215

  • AIDS Care CRS

    Rochester, New York, 14642-0001

  • McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit

    Rochester, New York, 14642-0001

  • Univ. of California Davis Med. Ctr., ACTU

    Sacramento, California

  • Ucsd, Avrc Crs

    San Diego, California, 92103

  • University of Washington AIDS CRS

    Seattle, Washington, 98104

Other trials in United States

Puerto Rico1 site

  • Puerto Rico-AIDS CRS

    San Juan, 00936-5067

Other trials in Puerto Rico

South Africa1 site

  • Wits HIV CRS

    Johannesburg, Gauteng

Other trials in South Africa

About this study

Official title: A Randomized, Phase II, Open Label Study to Compare Twice Daily and Once Daily Potent Antiretroviral Therapy and to Compare Self-Administered Therapy and Therapy Administered Under Direct Observation

Anti-HIV drug therapy works best when the drugs are taken exactly as prescribed by a doctor. Because anti-HIV therapy often involves multiple drugs, some people have difficulty taking them all correctly. The easier it is to take anti-HIV drugs, the more likely people will take them as prescribed and get the best results. This study will see if people are more successful in taking anti-HIV drugs once a day or twice a day. It also will determine if having a health care professional oversee each weekday dose helps people control their HIV infection. The study will compare taking a three-drug combination twice a day versus taking a three-drug combination just once a day. The study will also compare patients taking the drugs on their own to patients taking the drugs in the presence of a clinical worker. Viral load (amount of HIV in the blood) and drug side effects will be measured.

Read the detailed description

While many factors contribute to the success or failure of antiretroviral therapy for HIV, among the most important are factors that influence adherence to a treatment regimen, such as duration of therapy, dosing frequency, pill burden, side effects, and patient behaviors. Inconsistent adherence or nonadherence to antiretroviral therapy can result in suboptimal drug exposure. Suboptimal drug exposure can, in turn, impact short- and long-term patient outcomes by increasing the likelihood of drug resistant HIV mutants and subsequent virologic and clinical failure. It is therefore essential to design treatment regimens that promote long-term adherence to potent antiretroviral therapy. This study will evaluate the relative contribution of reduced-frequency dosing and directly observed therapy on the magnitude and durability of virologic suppression in patients treated with potent antiretroviral therapy.

Patients will be randomly assigned to one of three study arms. Arms A, B, and C receive the same daily dosage of lopinavir/ritonavir (LPV/r), emtricitabine (FTC), and stavudine extended release (d4T XR) or tenofovir DF (TDF). In Arm A, drugs are self-administered for 48 weeks; LPV/r is taken twice daily and FTC and d4T XR or TDF once daily. In Arm B, all drugs are self-administered once daily for 48 weeks. In Arm C, drugs are taken once a day under directly observed therapy during Weeks 0-24, and then by self-administration during Weeks 25-48. Adherence to the regimen is measured using an electronic drug monitoring system. Viral load, CD4 and CD8 T cell responses, population pharmacokinetics, and quality of life indicators are measured throughout the study. The tolerability and safety of the treatment regimens are also monitored.

Conditions
HIV Infections
Being tested
lopinavir/ritonavir, emtricitabine, stavudine, tenofovir DF
Keywords
Lopinavir, HIV-1, Drug Administration Schedule, Stavudine, HIV Protease Inhibitors, Ritonavir, Reverse Transcriptase Inhibitors, Self Care, Viral Load, Emtricitabine, Directly Observed Therapy, Tenofovir Disoproxil Fumarate, Treatment Naive
Medical subject headings
HIV Infections, Directly Observed Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lopinavir/ritonavirDrug

  • emtricitabineDrug

  • stavudineDrug

  • tenofovir DFDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2002 (estimated)
  2. Study completionJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00036452
Sponsor's protocol ID
A5073
Other IDs
10073, ACTG A5073, AACTG A5073
Status last verified
Oct 2021
First submitted
10 May 2002
Last updated
1 Nov 2021
Results posted
No

Publications

  • Liu H, Golin CE, Miller LG, Hays RD, Beck CK, Sanandaji S, Christian J, Maldonado T, Duran D, Kaplan AH, Wenger NS. A comparison study of multiple measures of adherence to HIV protease inhibitors. Ann Intern Med. 2001 May 15;134(10):968-77. doi: 10.7326/0003-4819-134-10-200105150-00011.

    PubMed 11352698

  • Paterson DL, Swindells S, Mohr J, Brester M, Vergis EN, Squier C, Wagener MM, Singh N. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med. 2000 Jul 4;133(1):21-30. doi: 10.7326/0003-4819-133-1-200007040-00004.

    PubMed 10877736

  • Volmink J, Matchaba P, Garner P. Directly observed therapy and treatment adherence. Lancet. 2000 Apr 15;355(9212):1345-50. doi: 10.1016/S0140-6736(00)02124-3.

    PubMed 10776760

  • Bangsberg DR, Mundy LM, Tulsky JP. Expanding directly observed therapy: tuberculosis to human immunodeficiency virus. Am J Med. 2001 Jun 1;110(8):664-6. doi: 10.1016/s0002-9343(01)00729-x. No abstract available.

    PubMed 11382379

  • Kirkland LR, Fischl MA, Tashima KT, Paar D, Gensler T, Graham NM, Gao H, Rosenzweig JR, McClernon DR, Pittman G, Hessenthaler SM, Hernandez JE; NZTA4007 Study Team. Response to lamivudine-zidovudine plus abacavir twice daily in antiretroviral-naive, incarcerated patients with HIV infection taking directly observed treatment. Clin Infect Dis. 2002 Feb 15;34(4):511-8. doi: 10.1086/338400. Epub 2002 Jan 4.

    PubMed 11797179

  • Gross R, Tierney C, Andrade A, Lalama C, Rosenkranz S, Eshleman SH, Flanigan T, Santana J, Salomon N, Reisler R, Wiggins I, Hogg E, Flexner C, Mildvan D; AIDS Clinical Trials Group A5073 Study Team. Modified directly observed antiretroviral therapy compared with self-administered therapy in treatment-naive HIV-1-infected patients: a randomized trial. Arch Intern Med. 2009 Jul 13;169(13):1224-32. doi: 10.1001/archinternmed.2009.172.

    PubMed 19597072

  • Flexner C, Tierney C, Gross R, Andrade A, Lalama C, Eshleman SH, Aberg J, Sanne I, Parsons T, Kashuba A, Rosenkranz SL, Kmack A, Ferguson E, Dehlinger M, Mildvan D; ACTG A5073 Study Team. Comparison of once-daily versus twice-daily combination antiretroviral therapy in treatment-naive patients: results of AIDS clinical trials group (ACTG) A5073, a 48-week randomized controlled trial. Clin Infect Dis. 2010 Apr 1;50(7):1041-52. doi: 10.1086/651118.

    PubMed 20192725

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lopinavir/ritonavir, emtricitabine and stavudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 29 sites in 3 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 6 inclusion and 9 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Puerto Rico, South Africa. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 NCT00036452, which also lists 7 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 1 Nov 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in