A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection
Study of Protease Inhibitor and/or Non-Nucleoside Reverse Transcriptase Inhibitor With Dual Nucleosides in Initial Therapy of HIV Infection
7 other identifiers
interventional
900
3 countries
78
Brief Summary
The purpose of this study is to compare the effectiveness of various combinations of anti-HIV drugs in HIV-positive men and women. Patients receive specific combinations of 3 or 4 of the following 6 drugs: didanosine (ddI), stavudine (d4T) efavirenz (EFV), nelfinavir (NFV), lamivudine (3TC), or zidovudine (ZDV). Anti-HIV therapy is effective in preventing the spread of HIV in the body. However, patients often experience unpleasant side effects and have difficulties following the dosing schedule. This study looks for combinations of anti-HIV drugs ("cocktails") which will be the most effective with the fewest problems.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2002
CompletedJune 7, 2012
June 1, 2012
November 2, 1999
June 5, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- \[Required: AS PER AMENDMENT 7/5/00:
- Chemoprophylaxis for Pneumocystis carinii pneumonia if CD4+ cell count is less than or equal to 200 cells/mm3.\]
- \[Suggested as an alternative agent for chemoprophylaxis against Mycobacterium avium complex:
- Azithromycin.\]
- \[Allowed: AS PER AMENDMENT 7/5/00:
- Topical and oral antifungal agents. Oral itraconazole may be administered concurrently with IDV if the dose of IDV is reduced to 600 mg every 8 hours.
- Treatment, maintenance, or chemoprophylaxis for opportunistic infections, as clinically indicated unless otherwise prohibited by the protocol.
- All antibiotics, as clinically indicated unless otherwise prohibited by the protocol.
- Systemic corticosteroid use for 21 days or less for acute problems, as medically indicated.
- Recombinant erythropoietin (rEPO, epoetin alfa, Epogen, epoetin beta, Marogen), granulocyte colony-stimulating factor (G-CSF, filgrastim, Neupogen), and granulocyte-macrophage colony-stimulating factor (GM-CSF, Regramostim).
- Regularly prescribed medications, such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, megestrol acetate (Megace), testosterone, or any other medications, as medically indicated unless otherwise prohibited by the protocol. NOTE: Due to the possibility that study medications may alter the effectiveness of oral contraceptives or depoprogesterone, these agents must not be used as the sole form of birth control, because the role of some study medications on the effectiveness of these methods has not yet been established.
- Alternative therapies, such as vitamins.
- Medications requiring low gastric pH if not administered at the same time as buffered ddI. Patients taking these agents should do so at least 2 hours before ddI.\]
- Vaccinations, if administered at least 2 weeks prior to an HIV RNA viral load evaluation.
- +24 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following condition are excluded:
- AIDS-related malignancy other than minimal Kaposi's sarcoma.
- Concurrent Medication:
- \[Excluded:
- AS PER AMENDMENT 7/5/00:
- Chronic systemic corticosteroids.
- For Steps 1 and 2, all antiretroviral therapies other than study medications. For step 3, contact the team to discuss potential addition or substitution with off-study antiretroviral medications.
- Investigational drugs without specific approval from the study chairs.
- Neurotoxic and pancreatotoxic drugs.
- Systemic cytotoxic chemotherapy.
- Amiodarone, astemizole, bepridil, cisapride, cholestyramine, ergot and ergot derivatives, flecainide, ganciclovir, interferon alfa, midazolam (unless used for sedation on ACTG 723), pimozide, propafenone, propoxyphene, quinidine, ribavirin, rifampin, sucralfate, terfenadine, and triazolam.
- Rifabutin for patients on RTV in Step 3 and for patients on Steps 1 and 2 because of the contradictory effects of EFV and NFV on plasma rifabutin levels. If a patient on Step 1 or 2 requires treatment with rifabutin after coming on the study, the team must be notified.
- Alpha tocopherol (vitamin E) supplementation since vitamin E is contained in the soft gelatin capsule formulation of APV.
- ddI concurrently with IV pentamidine.
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (80)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Willow Clinic
Menlo Park, California, 94025, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859, United States
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699, United States
Marin County Specialty Clinic
San Rafael, California, 94903, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107, United States
Stanford Univ Med Ctr
Stanford, California, 943055107, United States
Harbor UCLA Med Ctr
Torrance, California, 90502, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Georgetown Univ Hosp
Washington D.C., District of Columbia, 20037, United States
Howard Univ
Washington D.C., District of Columbia, 20059, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Emory Univ
Atlanta, Georgia, 30308, United States
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, 303652225, United States
Univ of Hawaii
Honolulu, Hawaii, 96816, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202, United States
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242, United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112, United States
Tulane Med Ctr Hosp
New Orleans, Louisiana, 70112, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112, United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114, United States
Boston Med Ctr
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112, United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Manhattan Veterans Administration / New York Univ Med Ctr
New York, New York, 10016, United States
Chelsea Ctr
New York, New York, 10021, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, 14642, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401, United States
Akron City Hospital
Akron, Ohio, 44304, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Univ of Kentucky Lexington
Cincinnati, Ohio, 45267, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850, United States
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Univ of Pittsburgh Med Ctr
Pittsburgh, Pennsylvania, 15213, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Univ of Texas Galveston
Galveston, Texas, 775550435, United States
Univ of Washington
Seattle, Washington, 98104, United States
Azienda Ospedaliera Umberto I
Ancona, Italy
Ospedale S Orsola
Bologna, Italy
Spedali Civili - Carosi
Brescia, Italy
Spedali Civili Cadeo
Brescia, Italy
Archispedale S Anna
Ferrara, Italy
Universita di Genova
Genova, Italy
Ospedale Luigi Cacco Moroni
Milan, Italy
Ospedale Luigi Sacco Cargnel
Milan, Italy
Azienda Ospedaliera di Parma
Parma, Italy
IRCCS Policlinico S Matteo Filice
Pavia, Italy
IRCCS Policlinico S Matteo Minoli
Pavia, Italy
Archispedale S Maria Nuova
Reggio Emilia, Italy
Universita di Roma - Delia
Roma, Italy
Ospedale Civile Maggiore
Verona, Italy
Univ of Puerto Rico
San Juan, 009365067, Puerto Rico
Azienda USL di Piacenza
Francesco Leoncini
Related Publications (14)
Smeaton LM, DeGruttola V, Robbins GK, Shafer RW. ACTG (AIDS Clinical Trials Group) 384: a strategy trial comparing consecutive treatments for HIV-1. Control Clin Trials. 2001 Apr;22(2):142-59. doi: 10.1016/s0197-2456(00)00126-4.
PMID: 11306153BACKGROUNDDube MP, Zackin R, Tebas P, et al. Prospective study of regional body composition in antiretroviral-naive subjects randomized to receive zidovudine+lamivudine or didanosine+stavudine combined with nelfinavir, efavirenz, or both: A5005s, a substudy of ACTG 384. Antiviral Ther. 2002;7:L18. Abstract 27.
BACKGROUNDSmith PF, Robbins G, Shafer R, Wu H, Yu S, Hirsch M, Merigan T, Morse GD, ACTG 384 Study Team. Effect of Efavirenz on the Pharmacokinetics of Nelfinavir and M8 in Naïve, HIV-infected Patients Receiving Long-term HAART Therapy. 10th Conference on Retroviruses and Oppurtunistic Infections. Feb 2003. Abstract 148.
BACKGROUNDShafer RW, Smeaton LM, Robbins GK, De Gruttola V, Snyder SW, D'Aquila RT, Johnson VA, Morse GD, Nokta MA, Martinez AI, Gripshover BM, Kaul P, Haubrich R, Swingle M, McCarty SD, Vella S, Hirsch MS, Merigan TC; AIDS Clinical Trials Group 384 Team. Comparison of four-drug regimens and pairs of sequential three-drug regimens as initial therapy for HIV-1 infection. N Engl J Med. 2003 Dec 11;349(24):2304-15. doi: 10.1056/NEJMoa030265.
PMID: 14668456RESULTRobbins GK, De Gruttola V, Shafer RW, Smeaton LM, Snyder SW, Pettinelli C, Dube MP, Fischl MA, Pollard RB, Delapenha R, Gedeon L, van der Horst C, Murphy RL, Becker MI, D'Aquila RT, Vella S, Merigan TC, Hirsch MS; AIDS Clinical Trials Group 384 Team. Comparison of sequential three-drug regimens as initial therapy for HIV-1 infection. N Engl J Med. 2003 Dec 11;349(24):2293-303. doi: 10.1056/NEJMoa030264.
PMID: 14668455RESULTReynolds NR, Testa MA, Marc LG, Chesney MA, Neidig JL, Smith SR, Vella S, Robbins GK; Protocol Teams of ACTG 384, ACTG 731 and A5031s. Factors influencing medication adherence beliefs and self-efficacy in persons naive to antiretroviral therapy: a multicenter, cross-sectional study. AIDS Behav. 2004 Jun;8(2):141-50. doi: 10.1023/B:AIBE.0000030245.52406.bb.
PMID: 15187476RESULTHulgan T, Haas DW, Haines JL, Ritchie MD, Robbins GK, Shafer RW, Clifford DB, Kallianpur AR, Summar M, Canter JA. Mitochondrial haplogroups and peripheral neuropathy during antiretroviral therapy: an adult AIDS clinical trials group study. AIDS. 2005 Sep 2;19(13):1341-9. doi: 10.1097/01.aids.0000180786.02930.a1.
PMID: 16103764RESULTSmith PF, Robbins GK, Shafer RW, Wu H, Yu S, Hirsch MS, Merigan TC, Park JG, Forrest A, Fischl MA, Morse GD; ACTG 384-5006 Team. Pharmacokinetics of nelfinavir and efavirenz in antiretroviral-naive, human immunodeficiency virus-infected subjects when administered alone or in combination with nucleoside analog reverse transcriptase inhibitors. Antimicrob Agents Chemother. 2005 Aug;49(8):3558-61. doi: 10.1128/AAC.49.8.3558-3561.2005.
PMID: 16048984RESULTHaas DW, Smeaton LM, Shafer RW, Robbins GK, Morse GD, Labbe L, Wilkinson GR, Clifford DB, D'Aquila RT, De Gruttola V, Pollard RB, Merigan TC, Hirsch MS, George AL Jr, Donahue JP, Kim RB. Pharmacogenetics of long-term responses to antiretroviral regimens containing Efavirenz and/or Nelfinavir: an Adult Aids Clinical Trials Group Study. J Infect Dis. 2005 Dec 1;192(11):1931-42. doi: 10.1086/497610. Epub 2005 Nov 1.
PMID: 16267764RESULTGandhi RT, Spritzler J, Chan E, Asmuth DM, Rodriguez B, Merigan TC, Hirsch MS, Shafer RW, Robbins GK, Pollard RB; ACTG 384 Team. Effect of baseline- and treatment-related factors on immunologic recovery after initiation of antiretroviral therapy in HIV-1-positive subjects: results from ACTG 384. J Acquir Immune Defic Syndr. 2006 Aug 1;42(4):426-34. doi: 10.1097/01.qai.0000226789.51992.3f.
PMID: 16810109RESULTMarc LG, Testa MA, Walker AM, Robbins GK, Shafer RW, Anderson NB, Berkman LF; ACTG Data Analysis Concept Sheet Study Team. Educational attainment and response to HAART during initial therapy for HIV-1 infection. J Psychosom Res. 2007 Aug;63(2):207-16. doi: 10.1016/j.jpsychores.2007.04.009.
PMID: 17662759RESULTLi B, Veturi Y, Verma A, Bradford Y, Daar ES, Gulick RM, Riddler SA, Robbins GK, Lennox JL, Haas DW, Ritchie MD. Tissue specificity-aware TWAS (TSA-TWAS) framework identifies novel associations with metabolic, immunologic, and virologic traits in HIV-positive adults. PLoS Genet. 2021 Apr 26;17(4):e1009464. doi: 10.1371/journal.pgen.1009464. eCollection 2021 Apr.
PMID: 33901188DERIVEDLok JJ, Hunt PW, Collier AC, Benson CA, Witt MD, Luque AE, Deeks SG, Bosch RJ. The impact of age on the prognostic capacity of CD8+ T-cell activation during suppressive antiretroviral therapy. AIDS. 2013 Aug 24;27(13):2101-10. doi: 10.1097/QAD.0b013e32836191b1.
PMID: 24326304DERIVEDLok JJ, Bosch RJ, Benson CA, Collier AC, Robbins GK, Shafer RW, Hughes MD; ALLRT team. Long-term increase in CD4+ T-cell counts during combination antiretroviral therapy for HIV-1 infection. AIDS. 2010 Jul 31;24(12):1867-76. doi: 10.1097/QAD.0b013e32833adbcf.
PMID: 20467286DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robert Shafer
- STUDY CHAIR
Gregory Robbins
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
November 1, 2002
Last Updated
June 7, 2012
Record last verified: 2012-06