Evidence map›Paper›PMID 11687611›Full record

Trial reportProceedings of the National Academy of Sciences of the United States of America2001

Structured antiretroviral treatment interruptions in chronically HIV-1-infected subjects.

G M Ortiz, M Wellons, J Brancato, H T Vo, R L Zinn, D E Clarkson, K Van Loon, S Bonhoeffer, G D Miralles, D Montefiori and 2 more

Registry-linked trialOpen access · greenAbstract readClinical TrialRandomized Controlled Trial
In one paragraph

Trial report in Proceedings of the National Academy of Sciences of the United States of America, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00080106 (A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Antiretroviral Effect of Immunization With the MRK Ad5 HIV-1 Gag Vaccine in HIV-1 Infected Individuals Who Interrupt Antiretroviral Therapy), which is not on this map. Cited by 51 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 1 pooled it
5.5field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00080106 phase2completednot on this mapstarted 2004, after this paper: background citation

A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Antiretroviral Effect of Immunization With the MRK Ad5 HIV-1 Gag Vaccine in HIV-1 Infected Individuals Who Interrupt Antiretroviral Therapy

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2004 to 2011Enrolled114ConditionsHIV InfectionsArmsMRK Ad5 HIV-1 gag vaccine, Vaccine placebo
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 1 synthesis or guideline pooled it, 159 citations in OpenAlex.

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  11. CD8medRxiv : the preprint server for health sciences · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 1 country.

G M OrtizGladstone Institute of Virology and Immunology, University of California, San Francisco, CA 94141-9100, USA. gortiz@gladstone.ucsf.edu
M Wellons
J Brancato
H T Vo
R L Zinn
D E Clarkson
K Van Loon
S Bonhoeffer
G D Miralles
D Montefiori
J A Bartlett
D F Nixon
Duke Medical Center · USDuke University Hospital · US

Funding

DYNAMICS OF HIV1 SPECIFIC CTL IN HIV1 INFECTIONR01AI044595 · NIAID · J. DAVID GLADSTONE INSTITUTES · PI NIXON, DOUGLAS F · 1999 to 2003
$1.3M
NON-NEUTRALIZING ANTIBODIES IN ACUTE PRIMARY HIV INFECTIONP01AI040237 · NIAID · DUKE UNIVERSITY · PI WEINHOLD, KENT J. · 1996 to 2000
$1.1M
K24 MID-CAREER CLINICAL INVESTIGATOR AWARDK24AI001744 · NIAID · DUKE UNIVERSITY · PI BARTLETT, JOHN A · 2000 to 2004
$417k
MINORITY PREDOCTORAL FELLOWSHIPF31GM020068 · NIGMS · WEILL MEDICAL COLLEGE OF CORNELL UNIV · PI ORTIZ, GABRIEL M · 1999 to 2002
$84k
NIAID NIH HHS AI40237NIAID NIH HHS K24 AI001744NIAID NIH HHS K24 AI01744NIAID NIH HHS R01 AI044595NIAID NIH HHS R01 AI44595NIGMS NIH HHS F31 GM020068NIGMS NIH HHS F31 GM20068NIGMS NIH HHS GM0773
6 · The paper itself

Abstract

The risks and benefits of structured treatment interruption (STI) in HIV-1-infected subjects are not fully understood. A pilot study was performed to compare STI with continuous highly active antiretroviral therapy (HAART) in chronic HIV-1-infected subjects with HIV-1 plasma RNA levels (VL) <400 copies per ml and CD4(+) T cells >400 per microl. CD4(+) T cells, VL, HIV-1-specific neutralizing antibodies, and IFN-gamma-producing HIV-1-specific CD8(+) and CD4(+) T cells were measured in all subjects. STIs of 1-month duration separated by 1 month of HAART, before a final 3-month STI, resulted in augmented CD8(+) T cell responses in all eight STI subjects (P = 0.003), maintained while on HAART up to 22 weeks after STI, and augmented neutralization titers to autologous HIV-1 isolate in one of eight subjects. However, significant decline of CD4(+) T cell count from pre-STI level, and VL rebound to pre-HAART baseline, occurred during STI (P = 0.001 and 0.34, respectively). CD4(+) T cell counts were regained on return to HAART. Control subjects (n = 4) maintained VL <400 copies per ml and stable CD4(+) T cell counts, and showed no enhancement of antiviral CD8(+) T cell responses. Despite increases in antiviral immunity, no control of VL was observed. Future studies of STI should proceed with caution.

Indexed as

Drug Administration ScheduleAdultAntiretroviral Therapy, Highly ActiveCD4 Lymphocyte CountCD8-Positive T-LymphocytesDrug Therapy, CombinationFemaleHIV-1HIV AntibodiesHIV InfectionsHIV Protease InhibitorsHumansMaleMiddle AgedNeutralization TestsReverse Transcriptase InhibitorsHIV AntibodiesHIV Protease InhibitorsReverse Transcriptase Inhibitors

Identifiers

PMID11687611
PMCPMC60863
OpenAlexW1966690073

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.