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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-05-31

Study Completion Date

2006-10-31

Brief Summary

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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.

Detailed Description

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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 This study evaluates if viral suppression can be sustained after study therapy is withdrawn.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

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HIV Infections

Keywords

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ritonavir

Intervention Type DRUG

Abacavir sulfate

Intervention Type DRUG

Amprenavir

Intervention Type DRUG

Lamivudine

Intervention Type DRUG

Stavudine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Volberding, MD

Role: STUDY_CHAIR

San Francisco Veterans Medical Center

Elizabeth Connick, MD

Role: STUDY_CHAIR

Infectious Disease Division, University of Colorado Health Sciences Center

Locations

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USC CRS

Los Angeles, California, United States

Site Status

UCLA CARE Center CRS

Los Angeles, California, United States

Site Status

Ucsd, Avrc Crs

San Diego, California, United States

Site Status

Ucsf Aids Crs

San Francisco, California, United States

Site Status

University of Colorado Hospital CRS

Aurora, Colorado, United States

Site Status

Univ. of Hawaii at Manoa, Leahi Hosp.

Honolulu, Hawaii, United States

Site Status

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, United States

Site Status

SSTAR, Family Healthcare Ctr.

Fall River, Massachusetts, United States

Site Status

Washington U CRS

St Louis, Missouri, United States

Site Status

Beth Israel Med. Ctr. ACTU

New York, New York, United States

Site Status

NY Univ. HIV/AIDS CRS

New York, New York, United States

Site Status

Columbia P&S CRS

New York, New York, United States

Site Status

AIDS Care CRS

Rochester, New York, United States

Site Status

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

Rochester, New York, United States

Site Status

Univ. of Rochester ACTG CRS

Rochester, New York, United States

Site Status

Unc Aids Crs

Chapel Hill, North Carolina, United States

Site Status

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, United States

Site Status

The Miriam Hosp. ACTG CRS

Providence, Rhode Island, United States

Site Status

Countries

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Puerto Rico United States

References

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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.

Reference Type BACKGROUND

PMID: 12008787 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12218387 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11416735 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12553479 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11873002 (View on PubMed)

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.

Reference Type RESULT

PMID: 19696651 (View on PubMed)

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.

Reference Type RESULT

PMID: 21637110 (View on PubMed)