AzTrials
AzTrials

HIV InfectionsPhase 2NCT00000940

Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected With HIV

A Phase 2 study testing Ritonavir, Abacavir sulfate and Amprenavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 18 sites in United States.

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

This study will determine what effect taking a combination of five anti-HIV drugs during the early stage of HIV infection, then temporarily stopping them once or twice, may have on the amount of HIV virus in the blood (viral load). Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
HIV Infections
What is being tested?
Ritonavir, Abacavir sulfate and Amprenavir
How many people
121 participants
Where
18 sitesUnited States
Study dates
May 1999to Oct 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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Acute HIV infection (recently infected with HIV or recent seroconversion)
  • Karnofsky status of 80 or greater within 14 days prior to study entry
  • Acceptable methods of contraception
  • Able and willing to give written informed consent

Who cannot join

  • Previously received anti-HIV drugs
  • Hepatitis within 30 days prior to study entry
  • Pancreatitis within 120 days prior to study entry
  • Radiation or chemotherapy within 30 days prior to study entry
  • Certain medications within 14 days prior to study entry
  • Experimental or investigational therapy within 30 days prior to study entry
  • Illness (non-HIV infection, cancer, etc.) at the time of study entry
  • Pregnant or breastfeeding

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • University of Colorado Hospital CRS

    Aurora, Colorado, 80045

  • Massachusetts General Hospital ACTG CRS

    Boston, Massachusetts, 02114

  • Unc Aids Crs

    Chapel Hill, North Carolina, 27514

  • SSTAR, Family Healthcare Ctr.

    Fall River, Massachusetts, 02720

  • Univ. of Hawaii at Manoa, Leahi Hosp.

    Honolulu, Hawaii, 96816

  • USC CRS

    Los Angeles, California, 90033

  • UCLA CARE Center CRS

    Los Angeles, California, 90035

  • Beth Israel Med. Ctr. ACTU

    New York, New York, 10003

  • NY Univ. HIV/AIDS CRS

    New York, New York, 10016

  • Columbia P&S CRS

    New York, New York, 10032

  • Hosp. of the Univ. of Pennsylvania CRS

    Philadelphia, Pennsylvania, 19104

  • The Miriam Hosp. ACTG CRS

    Providence, Rhode Island, 02906

  • AIDS Care CRS

    Rochester, New York, 14607

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

    Rochester, New York, 14642

  • Univ. of Rochester ACTG CRS

    Rochester, New York, 14642

  • Ucsd, Avrc Crs

    San Diego, California, 92103

  • Ucsf Aids Crs

    San Francisco, California, 94110

  • Washington U CRS

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase II Trial to Evaluate the Safety and Efficacy of Induction Treatment With Lamivudine Plus Stavudine Plus Abacavir Plus Amprenavir/Ritonavir Followed by Supervised Treatment Interruption in Subjects With Acute HIV Infection or Recent Seroconversion

This study will determine what effect taking a combination of five anti-HIV drugs during the early stage of HIV infection, then temporarily stopping them once or twice, may have on the amount of HIV virus in the blood (viral load). The study will also evaluate the safety and effectiveness of this anti-HIV drug combination.

Read the detailed description

Acute, primary HIV infection represents a potentially unique opportunity to eradicate the infection. Although plasma viral load rises rapidly, the dominant infecting virus is relatively uniform genetically, and infection may not be fully established in all tissue sites until some time after exposure. Current antiretroviral therapy is able to reduce plasma viral load to unmeasurable levels in established infection. However, there are many questions that remain about the treatment of primary HIV infection. While it is assumed that aggressive antiretroviral regimens are required, it is not known how long they must be continued. It is hoped that after an interval of aggressive therapy, the number of agents could be safely reduced. This study evaluates if viral suppression can be sustained after study therapy is withdrawn.

Participants in this study will receive lamivudine (3TC), stavudine (d4T), abacavir (ABC), amprenavir (APV), and ritonavir (RTV) for at least 52 weeks. During this induction phase, participants will be followed through regular study visits every 4 or 8 weeks. If the participant's viral load and CD4 counts are within study parameters at the end of 52 weeks, the participant will discontinue all antiretroviral medications simultaneously. Participants in the treatment interruption phase will be followed weekly initially, every 2 weeks for 8 weeks, and then every 4 or 8 weeks. Treatment may be restarted if necessary during this phase based on viral load and CD4 counts. If treatment is restarted, the participant will receive 3TC, d4T, APV, and RTV but not ABC. During this reinduction phase, participants will be followed every 4 or 8 weeks.

Depending on viral load and CD4 counts, participants may be eligible for a second treatment interruption phase following the reinduction phase. Participants will once again stop all antiretroviral medications simultaneously and will have the same monitoring as in the first treatment interruption phase. Following this second treatment interruption, participants will be restarted on 3TC, d4T, APV, and RTV and will be evaluated at Weeks 4, 8, 16, and 24, at which time participants go off study.

The length of study participation for individual participants will vary. The length of each phase will be highly dependent on the participant's laboratory parameters. In general, participants will be enrolled in the study for 3 to 4 years. Participants may also enroll in immunology, compartment, pharmacology, and medication compliance substudies.

Conditions
HIV Infections
Being tested
Ritonavir, Abacavir sulfate, Amprenavir, Lamivudine, Stavudine
Keywords
Drug Therapy, Combination, Stavudine, Amprenavir/Ritonavir, Protease Inhibitors, Lamivudine, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Abacavir Sulfate, Acute Infection, Treatment Interruption
Medical subject headings
HIV Infections

What participants receive

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

Timeline

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

  1. First posted31 Aug 2001 (estimated)
  2. Study startMay 1999
  3. Study completionOct 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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000940
Sponsor's protocol ID
ACTG 371
Other IDs
10099, ACTG 710 (substudy), ACTG 711 (substudy), ACTG 729 (substudy), ACTG 709 (substudy), AACTG 371
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
29 Oct 2021
Results posted
No

Publications

  • Ait-Khaled M, Rakik A, Griffin P, Cutrell A, Fischl MA, Clumeck N, Greenberg SB, Rubio R, Peters BS, Pulido F, Gould J, Pearce G, Spreen W, Tisdale M, Lafon S; CNA3003 International Study Team. Mutations in HIV-1 reverse transcriptase during therapy with abacavir, lamivudine and zidovudine in HIV-1-infected adults with no prior antiretroviral therapy. Antivir Ther. 2002 Mar;7(1):43-51.

    PubMed 12008787

  • Garcia F, Plana M, Mestre G, Arnedo M, Gil C, Miro JM, Cruceta A, Pumarola T, Gallart T, Gatell JM. Immunological and virological factors at baseline may predict response to structured therapy interruption in early stage chronic HIV-1 infection. AIDS. 2002 Sep 6;16(13):1761-5. doi: 10.1097/00002030-200209060-00008.

    PubMed 12218387

  • Garcia F, Plana M, Ortiz GM, Bonhoeffer S, Soriano A, Vidal C, Cruceta A, Arnedo M, Gil C, Pantaleo G, Pumarola T, Gallart T, Nixon DF, Miro JM, Gatell JM. The virological and immunological consequences of structured treatment interruptions in chronic HIV-1 infection. AIDS. 2001 Jun 15;15(9):F29-40. doi: 10.1097/00002030-200106150-00002.

    PubMed 11416735

  • Mira JA, Macias J, Nogales C, Fernandez-Rivera J, Garcia-Garcia JA, Ramos A, Pineda JA. Transient rebounds of low-level viraemia among HIV-infected patients under HAART are not associated with virological or immunological failure. Antivir Ther. 2002 Dec;7(4):251-6. doi: 10.1177/135965350200700404.

    PubMed 12553479

  • Tilling R, Kinloch S, Goh LE, Cooper D, Perrin L, Lampe F, Zaunders J, Hoen B, Tsoukas C, Andersson J, Janossy G; Quest Study Group. Parallel decline of CD8+/CD38++ T cells and viraemia in response to quadruple highly active antiretroviral therapy in primary HIV infection. AIDS. 2002 Mar 8;16(4):589-96. doi: 10.1097/00002030-200203080-00010.

    PubMed 11873002

  • Volberding P, Demeter L, Bosch RJ, Aga E, Pettinelli C, Hirsch M, Vogler M, Martinez A, Little S, Connick E; ACTG 371 Team. Antiretroviral therapy in acute and recent HIV infection: a prospective multicenter stratified trial of intentionally interrupted treatment. AIDS. 2009 Sep 24;23(15):1987-95. doi: 10.1097/QAD.0b013e32832eb285.

    PubMed 19696651

  • Connick E, Bosch RJ, Aga E, Schlichtemeier R, Demeter LM, Volberding P; ACTG 709 Team. Augmented HIV-specific interferon-gamma responses, but impaired lymphoproliferation during interruption of antiretroviral treatment initiated in primary HIV infection. J Acquir Immune Defic Syndr. 2011 Sep 1;58(1):1-8. doi: 10.1097/QAI.0b013e318224d0c7.

    PubMed 21637110

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ritonavir, Abacavir sulfate and Amprenavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 18 sites in United States.

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 4 inclusion and 8 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 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. 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 NCT00000940, 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 29 Oct 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